2 survey

Sister Study Breast Cancer Follow-up Implementation Plan
1) When patient informs us of her diagnosis, send card with list of resources.
2) 12-18 months post-diagnosis (to allow time for treatment completion), send brief letter to let
the patient know we will be calling her to ask questions about her breast cancer diagnosis
and treatment. Enclose the Breast Cancer Follow-up Worksheet to help the patient
prepare for the call.
3) Within one to two weeks after sending letter, telephone the patient to administer the
computer-assisted telephone interview and ask patient to identify physicians (including,
if any, a primary physician responsible for coordinating care) and treatment facilities.
Discuss authorization for obtaining medical record information about breast cancer diagnosis
and treatment and collecting samples of breast tissue remaining from biopsy or surgery.
4) After the telephone call, send patient a follow-up letter including the list of the physicians
she identified and two authorization forms for the release of medical records/information and
for the release of pathology blocks and slides. The mailing also includes a comprehensive
FAQ covering both requests and instructions for completing and returning the materials. The
letter instructs patients to mail the signed authorization forms and the physician list to the
Sister Study in the enclosed return envelope.
5) If signed authorization forms have not been received from patient within four weeks,
telephone the patient in an attempt to retrieve the forms.
6) After receiving patient’s signed medical record authorization forms, telephone one or
more of her physicians to let them know we will be requesting medical information, ask who
should receive the request, and find out if reimbursement of costs by the Sister Study will be
necessary.
7) Send letters to one or more physicians to request copies of relevant medical records and
pathology reports and ask them to fill out an enclosed medical report form. Enclose a copy
of the patient’s signed medical record authorization form. Enclose a descriptive
summary about the Sister Study.
8) If medical report forms and associated records have not been received from the physician
within 3-6 weeks, telephone the physician to ask them to send the materials.
9) Review medical report forms and associated records received from the physicians. If any of
the forms are missing information or records were not enclosed, contact the appropriate
physicians in an attempt to retrieve the information.
10) Send letter and checklist to the pathologist to request two blocks containing representative
samples of the breast carcinoma, two blocks containing normal breast tissue, and original
diagnostic H&E slides. Enclose a copy of the patient’s signed authorization form for
release of pathology specimens.
11) After receiving pathology specimens, send a thank you letter to the pathologist to acknowledge
receipt and provide information for retrieving the samples from study staff if needed.

Sister Study - Breast Cancer Follow-up, Patient Contact Letter

DATE
FIRST NAME LAST NAME
ADDRESS 1
ADDRESS 2
CITY, STATE ZIP
Dear Ms. LAST NAME:
Thank you for providing an update on your health to the Sister Study. We were sorry to hear of
your breast cancer diagnosis, and hope you are doing well. An important part of the Sister Study
is to follow-up with each participant who has developed breast cancer to obtain additional
information. In about two weeks, a member of the Sister Study staff will call to request
information on your diagnosis and treatment, including names and addresses of your health care
providers. Enclosed you will find a worksheet to help you prepare for the call. The worksheet
will give you an idea of what we will be asking you. We will not be collecting the worksheet. If
there is a question you cannot answer then just leave it blank. Some women find it helpful to
complete the worksheet before the telephone call. Although you may have told us some of the
details of your breast cancer diagnosis when you reported it to us, we need to collect the
information now in a standard way.
We appreciate your on-going participation in the Sister Study, especially at this time. The
information that you and other women are sharing is critical in helping us learn about the
environmental and genetic causes of breast cancer, and factors that may influence long-term
health in women who have been diagnosed with breast cancer.
Thank you for your support of this important research.
Sincerely,

Dale P. Sandler, Ph.D.
Principal Investigator
Encl: Breast Cancer Follow-up Worksheet

Breast Cancer Follow-up Worksheet – This worksheet will help you prepare for your telephone
interview. Please review these questions about your diagnosis and treatment, answering as best you can for each breast tumor
found. Do not worry if you cannot provide all of the information. Have this form with you during your telephone interview to
help you answer questions. If you have a copy of the pathology report related to your breast cancer diagnosis, it may help you
answer these questions. You may want to keep it with this form for your interview.

Diagnosis
What is the date a doctor first told you that you definitely had breast
cancer?
At the time of your breast cancer diagnosis, had the cancer spread to your
lymph nodes?

/
month

/
day

year

Yes

No

At diagnosis, had the cancer metastasized or spread to other parts of your
body?

Yes

No

Was the tumor invasive or in situ cancer?

Invasive

in situ

Was the tumor in ducts (ductal) or lobules (lobular) or both?

Tumor in ducts

Tumor in lobules

At the time of diagnosis, what was the size of the breast tumor?

.

Tumor in ducts
and lobules

cm

Was the tumor estrogen receptor positive or “ER positive?”

Yes, ER Positive

No, ER Negative

Was the tumor progesterone receptor positive or “PR positive?”

Yes, PR Positive

No, PR Negative

Was the HER2 (HER2NEU) test positive or negative?

Positive

Negative

Have you had surgery, not counting a biopsy, to remove the breast cancer?

Yes

No

Did you have chemotherapy for this breast cancer?

Yes

No

HER2NEU test
not performed

Treatment

What chemotherapy drugs were you given for this cancer?

_____________________________________________

Have you taken Tamoxifen, Evista, or Raloxifene as part of your breast
cancer treatment?

Page 1

Yes

Continue on Reverse

No

V. Date 12/01/08

Have you taken aromatase inhibitors like Arimidex (anastrozole), Femara
(letrozole), or Aromasin (exemestane) as part of your breast cancer
treatment?

Yes

No

Since your breast cancer diagnosis, have you taken Herceptin
(Trastuzumab)?

Yes

No

Have you had radiation therapy for this breast cancer?

Yes

No

Doctors and Medical Care Facilities:
Provider

Please list the name, address, and telephone number for each treatment provider or location.

Name

Main doctor or facility
responsible for breast cancer
diagnosis and treatment
Oncologist or oncology
center
(if different from above)

Surgeon or surgery center

Pathologist

Therapeutic Radiologist or
radiology center
Any other doctors or
facilities involved in your
breast cancer diagnosis and
treatment

Address
Street #

___________________________________________

City/Town

___________________________________________

State/Zip

___________________________________________

Street #

___________________________________________

City/Town

___________________________________________

State/Zip

___________________________________________

Street #

___________________________________________

City/Town

___________________________________________

State/Zip

___________________________________________

Street #

___________________________________________

City/Town

___________________________________________

State/Zip

___________________________________________

Street #

___________________________________________

City/Town

___________________________________________

State/Zip

___________________________________________

Street #

___________________________________________

City/Town

___________________________________________

State/Zip

___________________________________________

Telephone Number

If you have any questions, please call the Sister Study toll-free at
1-877-4SISTER (1-877-474-7837). Thank you!
Page 2

National Institute of Environmental Health Sciences / National Institutes of Health / U.S. Department of Health and Human Services

V. Date 12/01/08

Form #: 32
Version #: 01 (V. date 11/19/08)

CASE Follow-up Telephone Interview

Table of Contents
IN.

INTRODUCTION

CA. DIAGNOSIS AND TREATMENT OF BREAST CANCER
CS. DIAGNOSIS AND TREATMENT OF SECOND BREAST CANCER
MR. MEDICAL RELEASE, TUMOR TISSUE AND PHYSICIAN IDENTIFICATION
CN. CONCLUSION

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Form #: 32
Version #: 01 (V. date 11/19/08)

IN: INTRODUCTION
IN0.

My name is (NAME) and I am a staff member from the Sister Study. We are following up on
your (phone call/note/email/form) indicating that you have been diagnosed with breast
cancer. We are sorry to hear about this and hope you are doing well.

IN1.

We’d like to ask you some additional questions about your diagnosis, the type of cancer, and
about any treatment or surgery you may have received. We also will ask you for permission
to contact your physician and/or the health care facility to obtain copies of your medical
records pertaining to the diagnosis and treatment of your breast cancer. This should take
about 15 minutes. You may not be able to answer all of the questions, but please just do
your best.
ENTER ‘1’ TO CONTINUE............. 1

IN2.

You should have received a worksheet with the letter we sent to you. It may be helpful for
you to refer to this during the interview.
Do you have the completed worksheet in front of you?

YES.................[IN5].............. .1
NO ................... .................. 2
CAN’T FILL OUT .. [IN5]............... 3

[ASK IN3 IF IN2 = NO]
IN3. Do you need a few minutes to retrieve the YES................... .................. 1
worksheet or to review it and collect
NO .................[IN5]............... 2
the information?
[ASK IN4 IF IN3 = YES]
IN4. Would you like me to wait while you [review/retrieve] the worksheet or call
you back?
WAIT – ENTER ‘1’ WHEN READY .[IN5]............... 1
CALL BACK ........................ [IN13] .............. 2
IN5.

Do you have a copy of the pathology report
related to your breast cancer diagnosis?

[ASK IN6 IF IN5 = YES]
IN6. Did you use the pathology report to
fill out your worksheet?

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YES................... .................. 1
NO ................ [CA1] .............. 2
REF ............... [CA1] .............. 7
DK................. [CA1] .............. 8

YES................ [CA1] .............. 1
NO ................ [CA1] .............. 2
REF ............... [CA1] .............. 7
DK................. [CA1] .............. 8

Form #: 32
Version #: 01 (V. date 11/19/08)

[IF PATI(NT REFUSED ON EARLIER CALLTO PROVIDE INFORMATION ON DOCTORS OR
MEDICAL FACILITIES BUT AGREED TO LET US CALL BACK (MR0d = YES), ASK:]
IN7. My name is (NAME) and I am a staff member from the Sister Study. We are following up on
some materials we sent you related to your breast cancer diagnosis. When we spoke with you
recently, you had reservations about allowing us to contact your physician and other health
care facilities. However, you agreed to review the forms authorizing the Sister Study to
obtain copies of your medical records pertaining to the diagnosis and treatment of your breast
cancer. Did you receive the medical authorization forms we sent?
YES.................[IN9]............... 1
NO ................... .................. 2
IN8.

We will resend the materials and call you back.

[ASK IN9 IF IN7 = YES]
IN9. Now that you have seen the forms, do
you think you may be willing to give
the Sister Study permission to contact your
physician and other health care facilities?

ENTER ‘1’ ........ [IN13] .............. 1
YES................... .................. 1
NO / UNSURE.... [IN12] .............. 2

[ASK IN10 IF IN9 = YES]
IN10. We need the names of the relevant doctors or health care facilities to prepare
the medical release forms. I would like to get that information from you now
and then we will send you new forms. We will not contact your doctors or
health care facilities unless you give us permission to do so by signing the
medical record release forms.
Do you need a few minutes to gather
YES................... .................. 1
information about the doctors and
NO ................ [MR1] .............. 2
medical facilities involved in the diagnosis
and treatment of your breast cancer?
[ASK IN11 IF IN10 = YES]
IN11. Would you like me to wait while you collect this information or call you
back when you are ready?
WAIT – ENTER ‘1’ WHEN READY [MR1] .............. 1
CALL BACK ........................ [IN13] .............. 2
[ASK IN12 IF IN9 = NO OR UNSURE]
IN12. If you change your mind about giving us
ENTER ‘1’ ........ [END] .............. 1
information on the doctors or medical
facilities, please call the
Sister Study toll-free number (1-877-4SISTER)
and follow directions for enrolled women.
IN13. What is a convenient time to call you back?
MONTH

[CLICK ON “APPOINTMENT” TAB]

YEAR

__________________________
TIME
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DAY

AM
PM

Form #: 32
Version #: 01 (V. date 11/19/08)

CA. DIAGNOSIS AND TREATMENT OF BREAST CANCER
CA1.

[VERIFY DATE OF DIAGNOSIS, IF PROVIDED.]
You have indicated that a doctor first
told you that you had breast cancer on
[fill date]. Is this correct?

YES.............. [CA2A]............... 1
NO ...................................... 2
DK....................................... 8

[ASK CA1a IF NO DATE PROVIDED OR IF CA1=NO, DK]
[CHECK ANSWER TO CA1a AGAINST DOB]
CA1a. What is the date a doctor first told you that you
definitely had breast cancer?

MONTH

|__|__|

|__|__|__|__|
YEAR
IF YEAR PROVIDED, GO TO CA2A

[ASK CA2 ONLY IF CA1 = NO OR DK AND CA1a YEAR = DK]
[CHECK ANSWER TO CA2 AGAINST DOB]
CA2. How old were you at the time of this diagnosis?
CA2A. Sometimes there is a delay between when a woman
first notices a lump, or a mammogram shows an
abnormality, and the final diagnosis of breast cancer.
How much time went by between when you first
realized there was a problem and when you were told
the diagnosis was breast cancer?

AGE
< 1 MONTH – DIAGNOSED VERY CLOSE TO
INITIAL IDENTIFICATION ............ 00
|__|__| MONTHS

CA2B. It sometimes takes several doctor appointments to make sure of the breast cancer diagnosis
and to run laboratory tests to identify its characteristics. When we refer to the ‘time of
diagnosis,’ we mean this period of time during which your cancer was confirmed and
characterized, not just the day you got the diagnosis.
When you were diagnosed with breast cancer, did you
have any form of general health care coverage,
including health insurance, pre-paid plans such as
HMOs, or government plans such as Medicare or
Medicaid?

YES...............
NO ...............
REF ..............
DK................

...................... 1
...................... 2
...................... 7
...................... 8

CA2C. Sometimes it takes several tests and procedures after
the diagnosis to find out how many tumors there are.
After that medical work was completed, how many
tumors had they found?
IF R SAYS DK, PROBE: How many tumors do you know
about?

|__| BREAST TUMORS

CA3. At the time of your breast cancer diagnosis, had the
cancer spread to your lymph nodes?

YES...............
NO ...............
REF ..............
DK................

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[IF DK OR REF, COUNT AS 1 TUMOR
FOR CA11-CA18, CA54 AND CS54]

...................... 1
...................... 2
...................... 7
...................... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

CA4.

How many lymph nodes were tested?

0 ................. .................[CA6]
|__|__| LYMPH NODES ............[CA5]
REF .............. ............... [CA4a]
DK................ ............... [CA4a]

[ASK CA4a ONLY IF CA4 IS REF OR DK:]
CA4a. Approximately how many lymph nodes were
tested? Was it…?

CA6.

0 nodes.......[CA6]................... 0
1-3 nodes ....... ...................... 1
4-9 nodes ....... ...................... 2
10-14 nodes .... ...................... 3
15-19 nodes .... ...................... 4
Or 20 or more nodes ................. 5
REF .............. ...................... 7
DK................ ...................... 8

[ASK CA5 ONLY IF CA4 IS NOT 0 OR IF CA4a IS NOT 0:]
CA5. How many lymph nodes were positive?

0 ................. .................[CA6]
|__|__| LYMPH NODES ............[CA6]
REF .............. ............... [CA5a]
DK................ ............... [CA5a]

[ASK CA5a ONLY IF CA5 IS REF OR DK]
CA5a. Approximately how many lymph nodes
were positive? Was it…?

0 nodes.......... ...................... 0
1-3 nodes ....... ...................... 1
4-9 nodes ....... ...................... 2
10-14 nodes .... ...................... 3
15-19 nodes .... ...................... 4
Or 20 or more nodes ................. 5
REF .............. ...................... 7
DK................ ...................... 8

At the time of your breast cancer diagnosis, were
you diagnosed with any other type of cancer or
was cancer found anywhere else?

YES................. .................... 1
NO .............. [CA8]................. 2
REF ............. [CA8]................. 7
DK............... [CA8]................. 8

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Form #: 32
Version #: 01 (V. date 11/19/08)

[ASK CA7 IF CA6 = YES:]
CA7. What other type or types of cancer were
you diagnosed with or where else was
cancer found at the time of your breast
cancer diagnosis? [
CHECK ALL THAT APPLY
IF R ANSWERS “SKIN CANCER,” PROBE: Was
this melanoma or non-melanoma skin
cancer?
IF R GIVES A CLINICAL RESPONSE THAT
DOES NOT MATCH A CATEGORY AND IS NOT
A PART OF THE BODY, PROBE: “What
specific part of the body did this cancer
affect?”

[BEGIN REPEATING RECORD]
[FOR EACH TYPE OF CANCER]:
CA7a. Was the [CANCER TYPE FROM CA7] cancer a
primary tumor or was it a tumor that had
metastasized or spread from your breast
cancer or some other cancer
[END REPEATING RECORD]
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ABDOMINAL ....... .................... 1
BASAL CELL SKIN CANCER ........... 1
BLADDER .......... .................... 1
BLOOD............. .................... 1
BONE .............. .................... 1
BOWEL ............ .................... 1
BRAIN.............. .................... 1
BREAST ............ .................... 1
CERVIX, CERVICAL .................... 1
COLON, COLORECTAL ................ 1
DUCTAL CARCINOMA IN SITU ........ 1
ENDOMETRIAL .... .................... 1
ESOPHAGEAL / ESOPHAGUS ......... 1
HODGKIN’S DISEASE .................. 1
INTESTINE, INTESTINAL .............. 1
KAPOSI’S SARCOMA ................... 1
KIDNEY AND RENAL PELVIS .......... 1
LARYNX............ .................... 1
LEUKEMIA ......... .................... 1
LIVER .............. .................... 1
LOBULAR CARCINOMA IN SITU (LCIS)1
LUNG .............. .................... 1
LYMPH NODES .... .................... 1
LYMPHOMA ....... .................... 1
MELANOMA SKIN CANCER ............ 1
MULTIPLE MYELOMA .................. 1
NON-HODGKIN’S LYMPHOMA ........ 1
ORAL CAVITY AND PHARYNX ........ 1
OVARY, OVARIAN .................... 1
PANCREAS......... .................... 1
RECTUM, RECTAL .................... 1
SKIN CANCER – OTHER ............... 1
SQUAMOUS CELL SKIN CANCER...... 1
STOMACH ......... .................... 1
THYROID .......... .................... 1
UTERUS, UTERINE .................... 1
OTHER1 SPECIFY: .................... 1
OTHER2 SPECIFY: .................... 1
OTHER3 SPECIFY: .................... 1

PRIMARY .......... .................... 1
METASTASIS—BREAST................. 2
METASTASIS—OTHER ................. 3
METASTASIS—DK SOURCE ............ 4
REF ................ .................... 7
DK.................. .................... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

CA8.

Since the time you were first diagnosed with
breast cancer, have you been diagnosed with any
other cancers, or has cancer been found anywhere
else, including another breast cancer?
[ASK CA9 IF CA8 = YES:]
CA9. What type or types of cancer were you
diagnosed with or where else was cancer
found after your original breast cancer
diagnosis? [
CHECK ALL THAT APPLY
IF R ANSWERS “SKIN CANCER,” PROBE: Was
this melanoma or non-melanoma skin
cancer?
IF R GIVES A CLINICAL RESPONSE THAT
DOES NOT MATCH A CATEGORY AND IS NOT
A PART OF THE BODY, PROBE: “What
specific part of the body did this cancer
affect?”

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YES................. .................... 1
NO ............. [CA11] ................ 2
REF ............ [CA11] ................ 7
DK.............. [CA11] ................ 8

ABDOMINAL ....... .................... 1
BASAL CELL SKIN CANCER ........... 1
BLADDER .......... .................... 1
BLOOD............. .................... 1
BONE .............. .................... 1
BOWEL ............ .................... 1
BRAIN.............. .................... 1
BREAST ............ .................... 1
CERVIX, CERVICAL .................... 1
COLON, COLORECTAL ................ 1
DUCTAL CARCINOMA IN SITU ........ 1
ENDOMETRIAL .... .................... 1
ESOPHAGEAL / ESOPHAGUS ......... 1
HODGKIN’S DISEASE .................. 1
INTESTINE, INTESTINAL .............. 1
KAPOSI’S SARCOMA ................... 1
KIDNEY AND RENAL PELVIS .......... 1
LARYNX............ .................... 1
LEUKEMIA ......... .................... 1
LIVER .............. .................... 1
LOBULAR CARCINOMA IN SITU (LCIS)1
LUNG .............. .................... 1
LYMPH NODES .... .................... 1
LYMPHOMA ....... .................... 1
MELANOMA SKIN CANCER ............ 1
MULTIPLE MYELOMA .................. 1
NON-HODGKIN’S LYMPHOMA ........ 1
ORAL CAVITY AND PHARYNX ........ 1
OVARY, OVARIAN .................... 1
PANCREAS......... .................... 1
RECTUM, RECTAL .................... 1
SKIN CANCER – OTHER ............... 1
SQUAMOUS CELL SKIN CANCER...... 1
STOMACH ......... .................... 1
THYROID .......... .................... 1
UTERUS, UTERINE .................... 1
OTHER1 SPECIFY: .................... 1
OTHER2 SPECIFY: .................... 1
OTHER3 SPECIFY: .................... 1

Form #: 32
Version #: 01 (V. date 11/19/08)

[BEGIN REPEATING RECORD]
[FOR EACH TYPE OF CANCER:]
CA9a. Was the [CANCER TYPE FROM CA9] cancer a
primary tumor or was it a tumor that had
metastasized or spread from your breast
cancer or some other cancer?

[CHECK ANSWER TO CA9b AGAINST DOB]
[ASK CA9b – CA9c IF CA9 ≠ BREAST]
CA9b. What is the date a doctor first told you that you
definitely had this [CANCER TYPE FROM CA9]
cancer?

PRIMARY .......... .................... 1
METASTASIS—BREAST................. 2
METASTASIS—OTHER ................. 3
METASTASIS—DK SOURCE ............ 4
REF ................ .................... 7
DK.................. .................... 8

|__|__|

|__|__|__|__|
MONTH
YEAR
IF YEAR PROVIDED, GO TO CA9a OR
CA10 IF NO OTHER CANCERS

[ASK CA9c ONLY IF CA9b YEAR = DK]
[CHECK ANSWER TO CA9c AGAINST DOB]
CA9c. How old were you at the time of this diagnosis?

AGE

[END REPEATING RECORD]
[IF CA8 = 1, ASK CA10, ELSE GO TO CA11]
CA10. Are you currently undergoing treatment for
[this cancer/these cancers]?

YES.................
NO .................
REF ................
DK..................

.................... 1
.................... 2
.................... 7
.................... 8

CA11. The next questions are about the characteristics of your breast cancer.
[FOR WOMEN REPORTING MULTIPLE BREAST CANCERS DIAGNOSED AT DIFFERENT TIMES (CA9 =
BREAST):]
We would like to find out about each of your breast cancer diagnoses. Please answer the following
questions referring to your first breast cancer diagnosis in [month, year]. Later in this interview, we
will ask similar questions about your [second/other] breast cancer [diagnosis/diagnoses].
[FOR WOMEN REPORTING MULTIPLE BREAST TUMORS DIAGNOSED AT TIME OF FIRST DIAGNOSIS: CA2C
> 1 OR CA7 = BREAST]
You indicated that you had [FILL CA2c (+ 1 IF CA7 = BREAST)] breast tumors diagnosed in [month,
year]. Please answer these questions separately for each tumor.
ENTER ‘1’ TO CONTINUE............. 1

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Form #: 32
Version #: 01 (V. date 11/19/08)

[BEGIN REPEATING RECORD IF (CA2C > 1) OR (CA7 = BREAST)]
[FOR EACH TUMOR REPORTED AT INITIAL DIAGNOSIS. IF ONLY ONE BREAST TUMOR REPORTED AT
INITIAL DIAGNOSIS, ONLY GO THROUGH SERIES CA12 – CA18A ONCE]
CA12. [IF CA2C > 1 OR CA7 = BREAST:
For the first tumor… / second tumor …]
In which breast was the tumor found?

LEFT BREAST .......................... 1
RIGHT BREAST......................... 2
REF ..................................... 7
DK....................................... 8

CA13. Was this tumor
invasive or in situ cancer?

INVASIVE ............................... 1
IN SITU ................................. 2
REF .................. .................. 7
DK.................... .................. 8

CA14. Was the tumor in ducts (ductal) or
lobules (lobular) or both?

DUCTS .................................. 1
LOBULES ............................... 2
BOTH ................................... 3
OTHER.................................. 4
REF ..................................... 7
DK....................................... 8

[ASK CA15 IF CA13 IS NOT IN SITU:]
CA15. At the time of diagnosis, what was the size
of the tumor?

|__|__|.|__| cm ..........[CA15B]
REF ............[CA15C]............. 7
DK ................. .................. 8

PROBE: AN INCH IS ABOUT 2.5 CENTIMETERS.
PROBE: IF A TUMOR IS VERY SMALL IT MAY BE
MEASURED IN MILIMETERS.
[ASK CA15A ONLY IF CA15 = DK:]
CA15A.Even though you don’t know the exact
size, at the time of diagnosis, what was
the approximate size of the tumor? Was
it…?
PROBE: AN INCH IS ABOUT 2.5 CENTIMETERS.
PROBE: IF A TUMOR IS VERY SMALL IT MAY BE
MEASURED IN MILIMETERS.

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Less than or equal to 1.0 cm [CA16]1
1.1 to 2.0 cm. [CA16] ................ 2
2.1 to 4.0 cm. [CA16] ................ 3
4.1 cm or more .. .................... 4
REF ........... [CA15C] ............... 7
DK............. [CA15C] ............... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

[ASK CA15B IF CA15 OR CA15A > 4 CM, ELSE GO TO CA16:]
CA15B. I want to confirm, you said this tumor was
YES............. [CA16] ..............1
more than 4 centimeters or more than an
NO ............. [CA15] ..............2
inch and a half. Is that correct?
REF ............ [CA16] ..............7
DK.............. [CA16] ..............8
PROBE: AN INCH IS ABOUT 2.5 CENTIMETERS.
PROBE: IF A TUMOR IS VERY SMALL IT MAY BE
MEASURED IN MILIMETERS.
[ASK CA15C IF CA15 = DK OR REF AND CA15A = DK OR REF:]
CA15C.Could you tell us in your own words what
RECORD VERBATIM:
you know about the size of this tumor?
______________________________
CA16. Was this tumor estrogen receptor positive, that is,
“ER positive?”

YES (ER POSITIVE) .................... 1
NO (ER NEGATIVE).................... 2
BORDERLINE / MARGINAL............ 3
TEST NOT DONE.. .................... 4
REF ................ .................... 7
DK.................. .................... 8

CA17. Was this tumor progesterone receptor positive,
that is, “PR positive?”

YES (PR POSITIVE) .................... 1
NO (PR NEGATIVE).................... 2
BORDERLINE / MARGINAL............ 3
TEST NOT DONE.. .................... 4
REF ................ .................... 7
DK.................. .................... 8

CA18. Was the HER2 (HER2NEU) test performed for this
tumor?

YES................. .................... 1
NO ............. [CA19] ................ 2
REF ............ [CA19] ................ 7
DK.............. [CA19] ................ 8

[ASK CA18A IF CA18 = YES:]
CA18A. Was the HER2 (HER2NEU) test positive?

[END REPEATING RECORD IF CA2C > 1 OR CA7 = BREAST]

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YES...................................... 1
NO ...................................... 2
REF ..................................... 7
DK....................................... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

CA19. Now we’d like to ask you a few questions about your treatment.
When you were undergoing diagnosis and
treatment of your [IF CA9 = BREAST: first] breast
cancer, did financial constraints keep you from
receiving medical treatment your doctors
recommended?

YES, SPECIFY: .... .................... 1
_____________________________
NO ................. .................... 2
REF ................ .................... 7
DK.................. .................... 8

IF YES, PROBE FOR DETAILS
CA20. Have you had surgery, not counting a biopsy,
to remove the breast cancer?

YES...................................... 1
NO ............... [CA24].............. 2
REF .............. [CA24].............. 7
DK................ [CA24].............. 8

[IF CA12 = RIGHT, ASK ABOUT RIGHT BREAST. IF CA12=LEFT, ASK ABOUT LEFT BREAST. IF
CA12=BOTH, VERIFY BOTH BREASTS. IF DK OR REF ASK IF LEFT OR RIGHT.]
[IF CA20 = YES AND CA12 = BOTH, ASK CA21
FOR EACH BREAST THEN SKIP TO CA23. IF
CA20 = YES AND CA12 = LEFT OR RIGHT,
ASK CA21 FOR THE AFFECTED BREAST,
THEN GO TO CA22.]
CA21.
For your [left/right] breast, did you have a
mastectomy, or did you have a lumpectomy,
or partial removal of breast tissue[? / IF CA9
= BREAST: the first time you were diagnosed
with breast cancer?]
[IF R HAD >1 SURGERY, PROBE: What was the
last procedure you had/ IF CA9 = BREAST: the
first time you were diagnosed with breast
cancer?]
MASTECTOMY ...................1
LUMPECTOMY OR PARTIAL
a. LEFT
REMOVAL OF BREAST ........2
BREAST:
REF ................................7
DK .................................8
MASTECTOMY ...................1
LUMPECTOMY OR PARTIAL
b. RIGHT
REMOVAL OF BREAST ........2
BREAST:
REF ................................7
DK .................................8

[ASK CA22 ONLY IF
CA12 = LEFT OR RIGHT.]

[ASK CA23 FOR EACH
BREAST WHERE CA21=1
OR 2]

CA22.
For your other breast,
did you also have a
mastectomy to prevent
breast cancer, that is, a
prophylactic
mastectomy?

CA23.
Did you have
reconstructive breast
surgery?

YES ...................... 1
NO ....................... 2
REF ...................... 7
DK ....................... 8

YES.......................1
NO .......................2
REF ......................7
DK........................8

YES ...................... 1
NO ....................... 2
REF ...................... 7
DK ....................... 8

YES.......................1
NO .......................2
REF ......................7
DK........................8

IF YES, CONFIRM: This is the
removal of a healthy breast
to prevent cancer.

CA24. Were you having regular menstrual periods at the
time you were diagnosed with breast cancer in
[month, year] and before you started treatment?

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YES.................
NO .................
REF ................
DK..................

.................... 1
.................... 2
.................... 7
.................... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

CA24a. Since the time of that diagnosis, have you
had both your ovaries removed?

[ASK C24B ONLY IF CA24a = 3]
CA24b. What month and year did you have both
ovaries removed?
CA25. Did you have chemotherapy for this breast cancer?

[ASK CA25A IF CA25 = YES]
CA25A.Did you get your chemotherapy as part of
a clinical trial?

[ASK CA25B IF CA25A = YES]
CA25B. Do you know what drug or
regimen you actually received?

[BEGIN REPEATING RECORD IF CA25 = YES]
CA26. [IF CA25A = YES AND CA25B ≠ YES]
What chemotherapy drugs were being tested in
this trial?
[IF CA25A ≠ YES OR CA25B = YES]
What chemotherapy drugs were you given for
this cancer?
CA26a. [IF CA25A = YES AND CA25B ≠ YES AND
CA26 ≠ REF, DK]
Were there other chemotherapy drugs
being tested in this trial?
[IF (CA25A ≠ YES OR CA25B = YES)
OR (CA25B ≠ YES AND CA26 = REF, DK)]
Were you given other chemotherapy
drugs for this cancer?
[END REPEATING RECORD]
CA27. What month and year did your chemotherapy begin for
this cancer?
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YES............. [CA25] ................ 1
NO ............. [CA25] ................ 2
NO-REMOVED BEFORE CANCER DX.. 3
REF ............ [CA25] ................ 7
DK.............. [CA25] ................ 8
|__|__|
MONTH

|__|__|__|__|
YEAR

YES................. .................... 1
NO ............. [CA31] ................ 2
REF ............ [CA31] ................ 7
DK.............. [CA31] ................ 8
YES ................. ...................... 1
NO.............. [CA26] .................. 2
REF............. [CA26] .................. 7
DK .............. [CA26] .................. 8

YES .................
NO..................
REF.................
DK ..................

...................... 1
...................... 2
...................... 7
...................... 8

(Self-Report: Drop Down List of
medications)
REF................... .................... 7
DK .................... .................... 8

YES ............. [CA26] .................. 1
NO.............. [CA27] .................. 2
REF............. [CA27] .................. 7
DK .............. [CA27] .................. 8

2 0
MONTH

YEAR

Form #: 32
Version #: 01 (V. date 11/19/08)

CA28. Have you completed your chemotherapy
treatment for this cancer?

YES................... .................. 1
NO ........... [CA30] .................. 2
REF .......... [CA30] .................. 7
DK............ [CA30] .................. 8

[ASK C29 IF CA28 = YES:]
CA29. What month and year did your chemotherapy end?

2 0
MONTH

[ASK CA30 IF CA24 = YES:]
CA30. Did your menstrual periods stop when you were
having chemotherapy treatments?

[ASK CA31 IF CA24 = YES:]
CA31. Since the time of your diagnosis, have
you had shots or other medications that
stopped your menstrual periods?

YES...................................... 1
NO ...................................... 2
REF ..................................... 7
DK....................................... 8

YES...................................... 1
NO ...................................... 2
REF ..................................... 7
DK....................................... 8

[ASK CA32 IF CA30 = YES OR CA31 = YES]
CA32. Did you go back to having regular
menstrual periods?

YES...................................... 1
NO ...................................... 2
REF ..................................... 7
DK....................................... 8

CA33. Have you taken Tamoxifen, Evista, or Raloxifene
as part of this breast cancer treatment?

[ASK CA34 – CA35 IF CA33 = YES:]
CA34. What month and year did you begin
taking Tamoxifen, Evista or Raloxifene?
CA35. Are you currently taking Tamoxifen, Evista
or Raloxifene?

[ASK CA36 IF CA35 = NO:]
CA36. What month and year did you stop taking
Tamoxifen, Evista or Raloxifene?
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YEAR

YES................. .................... 1
NO ............. [CA38] ................ 2
UNSURE, WAS IN TRIAL[CA38] ...... 3
REF ............ [CA38] ................ 7
DK.............. [CA38] ................ 8

2 0
MONTH

YEAR

YES............. [CA38] ................ 1
NO ................. .................... 2
REF ............ [CA38] ................ 7
DK.............. [CA38] ................ 8

2 0
MONTH

YEAR

Form #: 32
Version #: 01 (V. date 11/19/08)

CA37. Omitted
CA38. Have you taken aromatase inhibitors like Arimidex
(anastrozole), Femara (letrozole), or Aromasin
(exemestane) as part of this breast cancer
treatment?

[ASK CA39 - CA40 IF CA38 = YES:]
CA39. What month and year did you begin
taking Arimidex (anastrozole),
Femara (letrozole), or Aromasin (exemestane)?
CA40. Are you currently taking Arimidex
(anastrozole) Femara (letrozole), or
Aromasin (exemestane)?

[ASK CA41 IF CA40 = NO:]
CA41. What month and year did you stop taking
Arimidex (anastrozole), Femara (letrozole),
or Aromasin (exemestane)?

YES................. .................... 1
NO ............. [CA43] ................ 2
UNSURE, WAS IN TRIAL[CA43] ...... 3
REF ............ [CA43] ................ 7
DK.............. [CA43] ................ 8

2 0
MONTH

YEAR

YES............. [CA43] ................ 1
NO ................. .................... 2
REF ............ [CA43] ................ 7
DK.............. [CA43] ................ 8

2 0
MONTH

YEAR

CA42. Omitted
CA43. Since your breast cancer diagnosis, have you taken
Herceptin (Trastuzumab)?

[ASK CA44 – CA45 IF CA43 = YES:]
CA44. What month and year did you begin
taking Herceptin (Trastuzumab)?
CA45. Are you currently taking Herceptin
(Trastuzumab)?

YES...................................... 1
NO ............. [CA48] ................ 2
UNSURE, WAS IN TRIAL[CA48] ...... 3
REF ............ [CA48] ................ 7
DK.............. [CA48] ................ 8

2 0
MONTH

YES............. [CA48] ................ 1
NO ................. .................... 2
REF ............ [CA48] ................ 7
DK.............. [CA48] ................ 8

[ASK CA46 IF CA45 = NO:]
CA46. What month and year did you stop taking
Herceptin (Trastuzumab)?
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YEAR

2 0
MONTH

YEAR

Form #: 32
Version #: 01 (V. date 11/19/08)

CA47. Omitted
CA48. Have you had radiation therapy for this breast cancer?

[ASK CA49 – CA50 IF CA48 = YES:]
CA49. What month and year did your radiation
therapy begin?
CA50. Are you still going through radiation
therapy for this breast cancer?

YES...................................... 1
NO ............ [CA52B] ............... 2
REF ........... [CA52B] ............... 7
DK............. [CA52B] ............... 8

2 0
MONTH

YES............. [CA52] ................ 1
NO ................. .................... 2
REF ............ [CA52] ................ 7
DK.............. [CA52] ................ 8

[ASK CA51 IF CA50 = NO:]
CA51. What month and year did your radiation
therapy end?

2 0
MONTH

CA52. To which areas did you have radiation for
this breast cancer?
CHECK ALL THAT APPLY

[ASK CA52A IF CA20 = YES]
CA52A.When was your radiation given? Was it…?
CHECK ALL THAT APPLY

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YEAR

YEAR

Breast: Whole Breast................. 1
Breast: “Limited field” just to
where your tumor was............. 1
Chest wall ........ .................... 1
Underarm (Axillary nodes) .......... 1
Other
(internal breast nodes or other
nodes not in your armpit) ......... 1
Other, specify_______________ ... 1
REF ................ .................... 7
DK.................. .................... 8

Before surgery ........................ 1
During surgery ........................ 1
After surgery .......................... 1
REF .................. .................. 7
DK.................... .................. 8

Form #: 32
Version #: 01 (V. date 11/19/08)

[BEGIN REPEATING RECORD]
[FOR EACH TRIAL R WAS IN FOR INITIAL BC DIAGNOSIS]
CA52B. [IF CA33 ≠ 3 AND CA38 ≠ 3 AND CA43 ≠ 3 AND CA52A ≠1]
Were you enrolled in a clinical trial or research
study for this breast cancer treatment or
management?
[IF CA33 = 3 OR CA38 = 3 OR CA43 = 3 OR CA25A = 1]
You mentioned earlier that you were enrolled in a
clinical trial or research study for this breast
cancer treatment or management – is that
correct?
[ALL - AFTER FIRST ITERATION] Were you enrolled
in another clinical trial or research study for this
breast cancer treatment or management?

YES................. .................... 1
NO ............. [CA53] ................ 2
REF ............ [CA53] ................ 7
DK.............. [CA53] ................ 8

[ASK CA52C-CA52F IF CA52B = YES:]
CA52C. What was the name, sponsor, or identification number of the study, if known?
[RECORD VERBATIM:] ________________________________________________________
CA52D.What was being tested in this trial?
CHECK ALL THAT APPLY

Chemotherapy type, timing, or dose
................... .................... 1
Radiation type, timing, or dose .... 1
Hormonal treatment ................. 1
Supportive care to prevent
complications of treatment....... 1
Surgical treatments .................. 1
OTHER, SPECIFY . .................... 1
_______________________________
REF ................ .................... 7
DK.................. .................... 8

CA52E. Is your participation in that study
ongoing?

YES............ [CA52B] ............... 1
NO ................... .................. 2
REF ........... [CA52B] ............... 7
DK............. [CA52B] ............... 8

[ASK CA52F IF CA52E = NO:]
CA52F. Did you complete all the treatments for
this study, leave the study before it
ended, or did the trial end before you
had finished all the treatments?
[END REPEATING RECORD]
CA53. Are there any other treatments for this breast cancer
you have had or plan to have that you can tell
us about?

COMPLETED ALL TREATMENTS ...... 1
LEFT BEFORE STUDY ENDED......... 2
TRIAL ENDED EARLY .................. 3
REF ................ .................... 7
DK.................. .................... 8

YES...................................... 1
[IF YES, RECORD VERBATIM:]
NO ...................................... 2

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Form #: 32
Version #: 01 (V. date 11/19/08)

[IF CA9 = BREAST SKIP TO CS1, ELSE CONTINUE]
[TOTAL NUMBER OF TUMORS REPORTED: CA2C + (1 IF CA7 = BREAST)]
CA54. I have recorded that you have been diagnosed
YES........... [MRIntro1] ............. 1
with a total of [FILL NUMBER] breast tumors to
NO ................. .................... 2
date. Is that correct?
DK.................. .................... 7
REF .......... [MRIntro1] ............. 8
[ASK CA55 IF CA54 = NO OR DK:]
CA55. Can you describe in your own words any breast cancer tumors that we did not ask you
about?
RECORD VERBATIM: _________________________________________________________

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Form #: 32
Version #: 01 (V. date 11/19/08)

DIAGNOSIS AND TREATMENT OF BREAST CANCER
SECOND SERIES OF QUESTIONS FOR WOMEN WITH MULTIPLE
BREAST CANCER DIAGNOSES AT DIFFERENT TIME POINTS
[IF CA9 = BREAST, CONTINUE, ELSE SKIP TO SECTION MR]
CS1.

OMITTED

[CHECK ANSWER TO CS1A AGAINST DOB]
CS1A. You have indicated you were diagnosed with
another breast cancer after your first diagnosis in
[month, year]. What was the date a doctor first
told you that you definitely had a second breast
cancer?

|__|__|
MONTH

|__|__|__|__|
YEAR

IF YEAR PROVIDED, GO TO CS2A

[ASK CS2 ONLY IF CS1A YEAR = DK]
[CHECK ANSWER TO CS2 AGAINST DOB]
CS2. How old were you at the time of this diagnosis?
CS2A. Sometimes there is a delay between when a woman
first notices a lump, or a mammogram shows an
abnormality, and the final diagnosis of breast cancer.
How much time went by between when you first
realized there was a problem and when you were told
the diagnosis was a second breast cancer?

AGE
< 1 MONTH – DIAGNOSED VERY CLOSE TO
INITIAL IDENTIFICATION ............ 00
|__|__| MONTHS

CS2B. It sometimes takes several doctor appointments to make sure of the breast cancer diagnosis
and to run laboratory tests to identify its characteristics. When we refer to the ‘time of
diagnosis,’ we mean this period of time during which your cancer was confirmed and
characterized, not just the day you got the diagnosis.
When you were diagnosed with breast cancer for a
second time, did you have any form of general health
care coverage, including health insurance, pre-paid
plans such as HMOs, or government plans such as
Medicare or Medicaid?
CS2C. Sometimes it takes several tests and procedures after
the diagnosis to find out how many tumors there are.
After that medical work was completed for your
second breast cancer, how many tumors had they
found?
IF R SAYS DK, PROBE: How many tumors do you know
about?

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YES...............
NO ...............
REF ..............
DK................

...................... 1
...................... 2
...................... 7
...................... 8

|__| BREAST TUMORS
[IF DK OR REF, COUNT AS 1 TUMOR
FOR CS11-CS18 AND CS54]

Form #: 32
Version #: 01 (V. date 11/19/08)

CS3.

At the time of your second breast cancer
diagnosis, had the cancer spread to your lymph
nodes?

YES...............
NO ...............
REF ..............
DK................

CS4.

How many lymph nodes were tested?

0 ................. ................. [CS6]
|__|__| LYMPH NODES ............ [CS5]
REF .............. ................[CS4a]
DK................ ................[CS4a]

[ASK CS4a ONLY IF CS4 IS REF OR DK:]
CS4a. Approximately how many lymph nodes were
tested? Was it…?

[ASK CS5 ONLY CS4 IS NOT 0 OR IF CS4a IS NOT 0:]
CS5. How many lymph nodes were positive?

[ASK CS5a ONLY IF CS5 IS REF OR DK]
CS5a. Approximately how many lymph nodes
were positive? Was it…?

CS6.
CS7.
CS7a.
CS8.
CS9.
CS9a.
CS10.

OMITTED
OMITTED
OMITTED
OMITTED
OMITTED
OMITTED
OMITTED

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...................... 1
...................... 2
...................... 7
...................... 8

0 nodes...... [CS11] .................. 0
1-3 nodes ....... ...................... 1
4-9 nodes ....... ...................... 2
10-14 nodes .... ...................... 3
15-19 nodes .... ...................... 4
Or 20 or more nodes ................. 5
REF .............. ...................... 7
DK................ ...................... 8

0 ................. ................[CS11]
|__|__| LYMPH NODES ...........[CS11]
REF .............. ................[CS5a]
DK................ ................[CS5a]

0 nodes.......... ...................... 0
1-3 nodes ....... ...................... 1
4-9 nodes ....... ...................... 2
10-14 nodes .... ...................... 3
15-19 nodes .... ...................... 4
Or 20 or more nodes ................. 5
REF .............. ...................... 7
DK................ ...................... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

CS11. The next questions are about the characteristics of your second breast cancer.
[FOR WOMEN REPORTING TWO BREAST TUMORS DIAGNOSED AT SAME TIME: (CS2C > 1)]
You indicated that you had [FILL CS2C] breast tumors diagnosed in [month, year]. Please answer
these questions separately for each tumor.
ENTER ‘1’ TO CONTINUE............. 1
[BEGIN REPEATING RECORD IF CS2C > 1]
[FOR EACH TUMOR REPORTED AT TIME OF SECOND DIAGNOSIS. IF ONLY ONE BREAST TUMOR
REPORTED AT TIME OF SECOND DIAGNOSIS, ONLY GO THROUGH SERIES CS12 – CS18A ONCE.]
CS12. [IF CS2C > 1: For the first tumor… / second tumor …]
In which breast was the tumor found?

LEFT BREAST .......................... 1
RIGHT BREAST......................... 2
REF ..................................... 7
DK....................................... 8

CS13. Was this tumor invasive or in situ cancer?

INVASIVE ............................... 1
IN SITU ................................. 2
REF .................. .................. 7
DK.................... .................. 8

CS14. Was the tumor in ducts (ductal) or lobules (lobular)
or both?

DUCTS .................................. 1
LOBULES ............................... 2
BOTH ................................... 3
OTHER.................................. 4
REF ..................................... 7
DK....................................... 8

[ASK CS15 IF CS13 IS NOT IN SITU:]
CS15. At the time of the second diagnosis, what
was the size of the tumor?

|__|__|.|__| cm ............ [CS15B]
REF ............[CS15C] ............... 7
DK.................. .................... 8

PROBE: AN INCH IS ABOUT 2.5 CENTIMETERS.
PROBE: IF A TUMOR IS VERY SMALL IT MAY
BE MEASURED IN MILIMETERS.
[ASK CS15A ONLY IF CS15 = DK:]
CS15A. Even though you don’t know the exact
size, at the time of the second diagnosis,
what was the approximate size of the
tumor? Was it…?
PROBE: AN INCH IS ABOUT 2.5 CENTIMETERS.
PROBE: IF A TUMOR IS VERY SMALL IT MAY
BE MEASURED IN MILIMETERS.
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Less than or equal to 1.0 cm [CS16]1
1.1 to 2.0 cm. [CS16] ................ 2
2.1 to 4.0 cm. [CS16] ................ 3
4.1 cm or more .. .................... 4
REF ............[CS15C] ............... 7
DK..............[CS15C] ............... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

[ASK CS15B IF CS15 OR CS15A > 4 CM, ELSE GO TO CS16:]
CS15B. I want to confirm, you said this tumor was
YES............. [CS16] ..............1
more than 4 centimeters or more than an
NO ............. [CS15] ..............2
inch and a half. Is that correct?
REF ............ [CS16] ..............7
DK.............. [CS16] ..............8
PROBE: AN INCH IS ABOUT 2.5 CENTIMETERS.
PROBE: IF A TUMOR IS VERY SMALL IT MAY
BE MEASURED IN MILIMETERS.
[ASK CS15C IF CS15 = DK OR REF AND CS15A = DK OR REF:]
CS15C. Could you tell us in your own words what
RECORD VERBATIM:
you know about the size of this tumor?
______________________________
CS16. Again, referring to the breast cancer diagnosed in
[month, year], was this tumor estrogen receptor
positive, that is, “ER positive?”

YES (ER POSITIVE) .................... 1
NO (ER NEGATIVE).................... 2
BORDERLINE / MARGINAL............ 3
TEST NOT DONE.. .................... 4
REF ................ .................... 7
DK.................. .................... 8

CS17. Was this tumor progesterone receptor positive,
that is, “PR positive?”

YES (PR POSITIVE) .................... 1
NO (PR NEGATIVE).................... 2
BORDERLINE / MARGINAL............ 3
TEST NOT DONE.. .................... 4
REF ................ .................... 7
DK.................. .................... 8

CS18. Was the HER2 (HER2NEU) test performed for this
tumor?

YES................. .................... 1
NO ............. [CS19] ................ 2
REF ............ [CS19] ................ 7
DK.............. [CS19] ................ 8

[ASK CS18A IF CS18 = YES:]
CS18A. Was the HER2 (HER2NEU) test positive?

[END REPEATING RECORD IF CS2C > 1]

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YES...................................... 1
NO ...................................... 2
REF ..................................... 7
DK....................................... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

CS19. Now we’d like to ask you a few questions about your treatment the second time you were
diagnosed with breast cancer.
When you were undergoing diagnosis and
treatment of your second breast cancer, did
financial constraints keep you from receiving
medical treatment your doctors recommended?
IF YES, PROBE FOR DETAILS
CS20. Have you had surgery not counting a biopsy
to remove the second breast cancer?

YES, SPECIFY: .... .................... 1
_____________________________
NO ................. .................... 2
REF ................ .................... 7
DK.................. .................... 8

YES...................................... 1
NO ................[CS25].............. 2
REF ...............[CS25].............. 7
DK.................[CS25].............. 8

[IF CS12 = RIGHT, ASK ABOUT RIGHT BREAST. IF CS12=LEFT, ASK ABOUT LEFT BREAST. IF
CS12=BOTH, VERIFY BOTH BREASTS. IF DK OR REF ASK IF LEFT OR RIGHT.]
[IF MASTECTOMY REPORTED IN FIRST DIAGNOSIS (CA21a THROUGH CA22b), SKIP CS21a – CS22b AS
NEEDED]
[IF CS20 = YES AND CS12 = BOTH, ASK CS21
FOR EACH BREAST THEN SKIP TO CS23. IF
CS20 = YES AND CS12 = LEFT OR RIGHT, ASK
CS21 FOR THE AFFECTED BREAST, THEN GO
TO CS22.]
CS21.
For your [left/right] breast, did you have a
mastectomy, or did you have a lumpectomy,
or partial removal of breast tissue the second
time you were diagnosed with breast cancer?
[IF R HAD >1 SURGERY, PROBE: What was the
last procedure you had the second time you
were diagnosed with breast cancer?]

a. LEFT
BREAST:

b. RIGHT
BREAST:

CS24.
CS24a.
CS24b.

MASTECTOMY ...................1
LUMPECTOMY OR PARTIAL
REMOVAL OF BREAST ........2
REF ................................7
DK .................................8
MASTECTOMY ...................1
LUMPECTOMY OR PARTIAL
REMOVAL OF BREAST ........2
REF ................................7
DK .................................8

[ASK CS22 ONLY IF CS12
= LEFT OR RIGHT.]

[ASK CS23 FOR EACH
BREAST WHERE CS21=1
OR 2]

CS22.
For your other breast,
did you also have a
mastectomy to prevent
breast cancer, that is, a
prophylactic
mastectomy?

CS23.
Did you have
reconstructive breast
surgery?

YES ...................... 1
NO ....................... 2
REF ...................... 7
DK ....................... 8

YES.......................1
NO .......................2
REF ......................7
DK........................8

YES ...................... 1
NO ....................... 2
REF ...................... 7
DK ....................... 8

YES.......................1
NO .......................2
REF ......................7
DK........................8

IF YES, CONFIRM: This is the
removal of a healthy breast
to prevent cancer.

Omitted
Omitted
Omitted
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Form #: 32
Version #: 01 (V. date 11/19/08)

CS25. Did you have chemotherapy for your second
breast cancer?

[ASK CS25A IF CS25 = YES]
CS25A. Did you get your chemotherapy as part of
a clinical trial?

[ASK CS25B IF CS25A = YES]
CS25B. Do you know what drug or
regimen you actually received?

[BEGIN REPEATING RECORD IF CS25 = YES]
CS26. [IF CS25A = YES AND CS25B ≠ YES]
What chemotherapy drugs were being tested in
this trial?
[IF CS25A ≠ YES OR CS25B = YES]
What chemotherapy drugs were you given for
your second breast cancer?
CS26a. [IF CS25A = YES AND CS25B ≠ YES AND
CS26 ≠ REF, DK]
Were there other chemotherapy drugs
being tested in this trial?
[IF (CS25A ≠ YES OR CS25B = YES)
OR (CS25B ≠ YES AND CS26 = REF, DK)]
Were you given other chemotherapy
drugs for your second breast cancer?
[END REPEATING RECORD]

YES ................. ...................... 1
NO.............. [CS31] .................. 2
REF............. [CS31] .................. 7
DK .............. [CS31] .................. 8

YES ................. ...................... 1
NO.............. [CS26] .................. 2
REF............. [CS26] .................. 7
DK .............. [CS26] .................. 8

YES .................
NO..................
REF.................
DK ..................

(Self-Report: Drop Down List of
medications)
REF................... .................... 7
DK .................... .................... 8

YES ............. [CS26] .................. 1
NO.............. [CS27] .................. 2
REF............. [CS27] .................. 7
DK .............. [CS27] .................. 8

2 0

CS27. What month and year did your chemotherapy begin for
your second breast cancer?
CS28. Have you completed this chemotherapy
treatment?

...................... 1
...................... 2
...................... 7
...................... 8

MONTH

YES ................. ...................... 1
NO.............. [CS33] .................. 2
REF............. [CS33] .................. 7
DK .............. [CS33] .................. 8

[ASK CS29 IF CS28 = YES:]
CS29. What month and year did your chemotherapy end?
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YEAR

2 0
MONTH

YEAR

Form #: 32
Version #: 01 (V. date 11/19/08)

CS30. Omitted
CS31. Omitted
CS32. Omitted
CS33. Have you taken Tamoxifen, Evista, or Raloxifene
as part of your treatment for the second breast
cancer?

[ASK CS34 – CS35 IF CS33 = YES:]
CS34. What month and year did you begin
taking Tamoxifen, Evista or Raloxifene?
CS35. Are you currently taking Tamoxifen, Evista
or Raloxifene?

[ASK CS36 IF CS35 = NO:]
CS36. What month and year did you stop taking
Tamoxifen, Evista or Raloxifene?

YES ................. ...................... 1
NO.............. [CS38] .................. 2
UNSURE–WAS IN TRIAL [CS38] ......... 3
REF............. [CS38] .................. 7
DK .............. [CS38] .................. 8

2 0
MONTH

YEAR

YES............. [CS38] ................ 1
NO ................. .................... 2
REF ............ [CS38] ................ 7
DK.............. [CS38] ................ 8

2 0
MONTH

YEAR

CS37. Omitted
CS38. Have you taken aromatase inhibitors like Arimidex
(anastrozole), Femara (letrozole), or Aromasin
(exemestane) as part of your treatment for the
second breast cancer?

[ASK CS39 - CS40 IF CS38 = YES:]
CS39. What month and year did you begin
taking Arimidex (anastrozole),
Femara (letrozole), or Aromasin (exemestane)?
CS40. Are you currently taking Arimidex
(anastrozole) Femara (letrozole), or
Aromasin (exemestane)?

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YES................. .................... 1
NO ............. [CS43] ................ 2
UNSURE–WAS IN TRIAL [CS43] ....... 3
REF ............ [CS43] ................ 7
DK.............. [CS43] ................ 8

2 0
MONTH

YEAR

YES............. [CS43] ................ 1
NO ................. .................... 2
REF ............ [CS43] ................ 7
DK.............. [CS43] ................ 8

Form #: 32
Version #: 01 (V. date 11/19/08)

[ASK CS41 IF CS40 = NO:]
CS41. What month and year did you stop taking
Arimidex (anastrozole), Femara (letrozole),
or Aromasin (exemestane)?

2 0
MONTH

YEAR

CS42. Omitted
CS43. Since your second breast cancer diagnosis, have
you taken Herceptin (Trastuzumab)?

[ASK CS44 – CS45 IF CS43 = YES:]
CS44. What month and year did you begin
taking Herceptin (Trastuzumab)?
CS45. Are you currently taking Herceptin
(Trastuzumab)?

YES...................................... 1
NO ................[CS48].............. 2
UNSURE, WAS IN TRIAL [CS48] ..... 3
REF ...............[CS48].............. 7
DK.................[CS48].............. 8

2 0
MONTH

YEAR

YES............. [CS48] ................ 1
NO ................. .................... 2
REF ............ [CS48] ................ 7
DK.............. [CS48] ................ 8

[ASK CS46 IF CS45 = NO:]
CS46. What month and year did you stop taking
Herceptin (Trastuzumab)?

2 0
MONTH

YEAR

CS47. Omitted
CS48. Have you had radiation therapy for your
second breast cancer?

YES...................................... 1
NO .............[CS52B] ............... 2
REF ............[CS52B] ............... 7
DK..............[CS52B] ............... 8

[ASK CS49 – CS50 IF CS48 = YES:]
CS49. What month and year did radiation
therapy begin for your second breast cancer?
CS50. Are you still going through radiation
therapy for this breast cancer?

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2 0
MONTH

YEAR

YES............. [CS52] ................ 1
NO ................. .................... 2
REF ............ [CS52] ................ 7
DK.............. [CS52] ................ 8

Form #: 32
Version #: 01 (V. date 11/19/08)

[ASK CS51 IF CS50 = NO:]
CS51. What month and year did your radiation
therapy end?
CS52. To which areas did you have radiation for your
second breast cancer?
CHECK ALL THAT APPLY

[ASK CS52A IF CS20 = YES]
CS52A. When was your radiation given? Was it…
CHECK ALL THAT APPLY

[BEGIN REPEATING RECORD]
[FOR EACH TRIAL R WAS IN AT TIME OF SECOND BC DIAGNOSIS]
CS52B. [IF CS33 ≠ 3 AND CS38 ≠ 3 AND CS43 ≠ 3 AND CS52A ≠1]
Were you enrolled in a clinical trial or research
study for the treatment or management of your
second breast cancer?
[IF CS33 = 3 OR CS38 = 3 OR CS43 = 3 OR CS25A = 1]
You mentioned earlier that you were enrolled in a
clinical trial or research study for the treatment
or management of your second breast cancer – is
that correct?
[ALL - AFTER FIRST ITERATION] Were you enrolled
in another clinical trial or research study for
treatment or management of your second breast
cancer?

2 0
MONTH

YEAR

Breast: Whole Breast................. 1
Breast: “Limited field” just to
where your tumor was............. 1
Chest wall ............................. 1
Underarm (Axillary nodes) .......... 1
Other ................................... 1
(internal breast nodes or other
nodes not in your armpit)
Other, specify__________________
REF .................. .................. 7
DK.................... .................. 8

Before surgery ........................ 1
During surgery ........................ 1
After surgery .......................... 1
REF .................. .................. 7
DK.................... .................. 8

YES................. .................... 1
NO ............. [CS53] ................ 2
REF ............ [CS53] ................ 7
DK.............. [CS53] ................ 8

[ASK CS52C-CS52F IF CS52B = YES:]
CS52C. What was the name, sponsor, or identification number of the study, if known?
[RECORD VERBATIM:] ________________________________________________________

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Form #: 32
Version #: 01 (V. date 11/19/08)

CS52D. What was being tested in this trial?
CHECK ALL THAT APPLY

Chemotherapy type, timing, or dose
................... .................... 1
Radiation type, timing, or dose .... 1
Hormonal treatment ................. 1
Supportive care to prevent
complications of treatment....... 1
Surgical treatments .................. 1
OTHER, SPECIFY . .................... 1
_______________________________
REF ................ .................... 7
DK.................. .................... 8

CS52E. Is your participation in that study
ongoing?

YES.............[CS52B] ............... 1
NO ................... .................. 2
REF ............[CS52B] ............... 7
DK..............[CS52B] ............... 8

[ASK CS52F IF CS52E = NO:]
CS52F. Did you complete all the treatments for
this study, leave the study before it
ended, or did the trial end before you
had finished all the treatments?

C OMPLETED ALL TREATMENTS ..... 1
LEFT BEFORE STUDY ENDED......... 2
TRIAL ENDED EARLY .................. 3
REF ................ .................... 7
DK.................. .................... 8

[END REPEATING RECORD]
CS53. Are there any other treatments for your second
breast cancer you have had or plan to have
that you can tell us about?

YES...................................... 1
[IF YES, RECORD VERBATIM:]
NO ...................................... 2

[TOTAL NUMBER OF TUMORS REPORTED: CA2C + (1 IF CA7 = BREAST) + (CS2C IF CA9 = BREAST)]
CS54. I have recorded that you have been diagnosed
YES........... [MRIntro1] ............. 1
with a total of [FILL NUMBER] breast tumors to
NO ................. .................... 2
date. Is that correct?
DK.................. .................... 7
REF .......... [MRIntro1] ............. 8
[ASK CS55 IF CS54 = NO OR DK:]
CS55. Can you describe in your own words any breast cancer tumors that we did not ask you
about?
RECORD VERBATIM: _________________________________________________________

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Form #: 32
Version #: 01 (V. date 11/19/08)

MR. MEDICAL RELEASE, TUMOR TISSUE AND PHYSICIAN IDENTIFICATION
MRIntro1. The Sister Study would like to get additional details about your breast cancer diagnosis
and treatment from your medical record, including a copy of your pathology report and a
sample of your breast biopsy tissue that the pathologist may have saved. We can only get this
information and tissue if you sign authorization forms. We would like to send you these forms
along with answers to questions some women have about them.
CONTINUE ............... 1
MRIntro2. If you sign the medical record release forms, we will contact the doctors and facilities
involved in your diagnosis and treatment and ask them to complete a short form and send us
copies of the sections of your records that pertain to your breast cancer. We will not share
with your doctor any of the information you have given to the Sister Study other than the fact
that you have told us you were diagnosed with breast cancer and that you have been
participating in the Sister Study. The information we get from your doctors and medical
records will be used for research only and will be kept confidential.
CONTINUE ............ 1
MRIntro3. We need the names of the relevant doctors or health care facilities to prepare the
medical release forms. If it is okay with you, I would like to get that information from you
now. You will have the opportunity to read the forms and decide for yourself if you would like
to sign them. We will not contact your doctors or health care facilities unless you give us
permission to do so by signing the forms.
[ANSWER QUESTIONS, REFERRING TO FAQS ABOUT MEDICAL RECORDS AND HIPAA]
CONTINUE ............ 1
MR0. May we ask you some questions about the doctors and medical
facilities involved in the diagnosis and treatment of your
breast cancer?
[ASK MR0a IF MR0 = YES]
MR0a. Do you need a few minutes to find your worksheet or to
gather information about the doctors and medical
facilities involved in the diagnosis and treatment of
your breast cancer?

YES.......... .................. 1
NO......... [MR0d] ........... 2

YES................. ........... 1
NO.......... [MR1] ............ 2

[ASK MR0b IF MR0a = YES]
MR0b. Would you like me to wait while you collect this information or call you
back when you are ready?
WAIT – ENTER ‘1’ WHEN READY [MR1] .............. 1
CALL BACK ........................... .................. 2
[ASK MR0c IF MR0b = CALL BACK]
MR0c. What is a convenient time to call you back?
[CLICK ON “APPOINTMENT” TAB]
MONTH

DAY

YEAR

__________________________
TIME
[ASK MR0d IF MR0 = NO]
MR0d. I would like to send you some information about
medical authorization forms and then contact you
again in a few weeks. May I do that?
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AM
PM

YES......... [CN2] ............ 1
NO.......... [CN3] ............ 2

Form #: 32
Version #: 01 (V. date 11/19/08)

IDENTIFICATION OF DOCTORS/HEALTH CARE FACILITIES
MR1.

Is there one doctor or health care facility that
was responsible for most of your breast cancer
diagnosis and treatment?

YES .......................................... 1
NO................... [MR2] ............... 2

MR1A. What is the first and last name of your doctor?

MR1aF. ___________________________
NA ............. [MR1aH] ................. NA
DK ............. [MR1aL] ................... 7
REF ............ [MR1aL] ................... 8
MR1aL. ___________________________
DK ............. [MR1aH] ................... 7
REF ............ [MR1aH] ................... 8

[RECORD DOCTOR’S FIRST NAME AND LAST
NAME. IF NO SPECIFIC DOCTOR, ENTER “NA.”]

MR1aH. What is the name of the health care facility
of your doctor?
[IF NO FACILITY NAME ENTER ‘NA’]
MR1A1.Was this where you had a…

_________________________________
NA .................. ...................... NA
DK .................. ........................ 7
REF ................. ........................ 8
biopsy?............. ........................ 1
tumor removal? .. ........................ 1
pathology sample tested?................ 1
REF ................. ........................ 7
DK .................. ........................ 8

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR1B. What is [Dr. NAME/this doctor]’s specialty?

PRIMARY CARE........................... 01
INTERNAL MEDICINE .................... 02
SURGEON ................................. 03
ONCOLOGIST............................. 04
PATHOLOGIST ........................... 05
RADIOLOGIST ............................ 06
OTHER .................................... 07
SPECIFY: ______________________
REF ........................................ 97
DK ......................................... 98

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR1C. Is [Dr. NAME/this doctor] in a group practice,
YES, GROUP................................ 1
that is, do other doctors practice at the same office, NO, SOLO................................... 2
or is [Dr. NAME/this doctor] part of a
REF .......................................... 7
medical facility or HMO?
DK ........................................... 8

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Form #: 32
Version #: 01 (V. date 11/19/08)

MR1D. What is the street address of [Dr. NAME/
FACILITY]?

MR1dStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR1dStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [Dr. NAME/ FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [Dr. NAME/ FACILITY]?

MR1dCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [Dr. NAME/
FACILITY]?

MR1dState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [Dr. NAME/FACILITY]?

MR1dZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR1E IF STREET ADDRESS = DK:]
MR1E. What is the nearest cross street or main
intersection to [Dr. NAME/ FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR1F. What is the telephone number for [Dr. NAME/
FACILITY]?

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MR1FArea.
REF.................
DK ..................
MR1FPref.
REF.................
DK ..................
MR1FLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

[IF MR1B NOT = ONCOLOGIST, ASK:]
MR2. Was there an oncologist or oncology center
involved in your breast cancer diagnosis or
treatment?
MR2A. What is the first and last name of your
oncologist?
[RECORD ONCOLOGIST’S FIRST NAME AND LAST
NAME. IF NO SPECIFIC DOCTOR, ENTER “NA.”]

MR2aH. What is the name of the health care facility
of your oncologist?
[IF NO FACILITY NAME ENTER ‘NA’]
MR2A1.Was this where you had a…

YES .......................................... 1
NO....................... [MR3] ............ 2

MR2aF. ___________________________
NA ............. [MR2aH] ................. NA
DK ............. [MR2aL] ................... 7
REF ............ [MR2aL] ................... 8
MR2aL. ___________________________
DK ............. [MR2aH] ................... 7
REF ............ [MR2aH] ................... 8
_________________________________
NA .................. ...................... NA
DK .................. ........................ 7
REF ................. ........................ 8
biopsy?............. ........................ 1
tumor removal? .. ........................ 1
pathology sample tested?................ 1
REF ................. ........................ 7
DK .................. ........................ 8

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR2B. Just to confirm, this was an oncologist?
IF NECESSARY, PROBE: What is [Dr. NAME /
this doctor]’s specialty?

PRIMARY CARE........................... 01
INTERNAL MEDICINE .................... 02
SURGEON ................................. 03
ONCOLOGIST............................. 04
PATHOLOGIST ........................... 05
RADIOLOGIST ............................ 06
OTHER .................................... 07
SPECIFY: ______________________
REF ........................................ 97
DK ......................................... 98

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR2C. Is [Dr. NAME/this doctor] in a group practice,
YES, GROUP................................ 1
that is, do other doctors practice at the same office, NO, SOLO................................... 2
or is [Dr. NAME/this doctor] part of a
REF .......................................... 7
medical facility or HMO?
DK ........................................... 8

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Form #: 32
Version #: 01 (V. date 11/19/08)

MR2D. What is the street address of [Dr. NAME/
FACILITY]?

MR2dStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR2dStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [Dr. NAME/ FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [Dr. NAME/ FACILITY]?

MR2dCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [Dr. NAME/
FACILITY]?

MR2dState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [Dr. NAME/FACILITY]?

MR2dZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR2E IF STREET ADDRESS = DK:]
MR2E. What is the nearest cross street or main
intersection to [Dr. NAME/ FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR2F. What is the telephone number for [Dr. NAME/
FACILITY]?

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MR2FArea.
REF.................
DK ..................
MR2FPref.
REF.................
DK ..................
MR2FLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

[IF MR1B AND MR2B NOT = SURGEON, ASK:]
MR3. Was there a surgeon or surgery center involved
in your breast cancer diagnosis or treatment?
MR3A. What is the first and last name of your
surgeon?
[RECORD SURGEON’S FIRST NAME AND LAST
NAME. IF NO SPECIFIC DOCTOR, ENTER “NA.”]

MR3aH. What is the name of the health care facility
of your surgeon?
[IF NO FACILITY NAME ENTER ‘NA’]
MR3A1.Was this where you had a…

YES .......................................... 1
NO....................... [MR4] ............ 2
MR3aF. ___________________________
NA ............. [MR3aH] ................. NA
DK ............. [MR3aL] ................... 7
REF ............ [MR3aL] ................... 8
MR3aL. ___________________________
DK ............. [MR3aH] ................... 7
REF ............ [MR3aH] ................... 8
_________________________________
NA .................. ...................... NA
DK .................. ........................ 7
REF ................. ........................ 8
biopsy?............. ........................ 1
tumor removal? .. ........................ 1
pathology sample tested?................ 1
REF ................. ........................ 7
DK .................. ........................ 8

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR3B. Just to confirm, this was a surgeon?
IF NECESSARY, PROBE: What is [Dr. NAME /
this doctor]’s specialty?

PRIMARY CARE........................... 01
INTERNAL MEDICINE .................... 02
SURGEON ................................. 03
ONCOLOGIST............................. 04
PATHOLOGIST ........................... 05
RADIOLOGIST ............................ 06
OTHER .................................... 07
SPECIFY: ______________________
REF ........................................ 97
DK ......................................... 98

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR3C. Is [Dr. NAME/this doctor] in a group practice,
YES, GROUP................................ 1
that is, do other doctors practice at the same office, NO, SOLO................................... 2
or is [Dr. NAME/this doctor] part of a
REF .......................................... 7
medical facility or HMO?
DK ........................................... 8

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Form #: 32
Version #: 01 (V. date 11/19/08)

MR3D. What is the street address of [Dr. NAME/
FACILITY]?

MR3dStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR3dStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [Dr. NAME/ FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [Dr. NAME/ FACILITY]?

MR3dCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [Dr. NAME/
FACILITY]?

MR3dState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [Dr. NAME/FACILITY]?

MR3dZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR3E IF STREET ADDRESS = DK:]
MR3E. What is the nearest cross street or main
intersection to [Dr. NAME/ FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR3F. What is the telephone number for [Dr. NAME/
FACILITY]?

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MR3FArea.
REF.................
DK ..................
MR3FPref.
REF.................
DK ..................
MR3FLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

[IF MR1B AND MR2B AND MR3B NOT = PATHOLOGIST, ASK:]
MR4. Do you know the name of the pathologist?

YES ..................... [MR4A] ........... 1
NO........................... ............... 2

MR4a1. Do you know where the pathology was done? YES .....................[MR4aH] .......... 1
NO....................... [MR5] ............ 2
MR4A. What is the first and last name of your
pathologist?
[RECORD PATHOLOGIST’S FIRST NAME AND
LAST NAME. IF NO SPECIFIC DOCTOR, ENTER
“NA.”]

MR4aH. What is the name of the health care facility
of your pathologist?
[IF NO FACILITY NAME ENTER ‘NA’]
MR4A1.Was this where you had a…

_________________________________
NA .................. ...................... NA
DK .................. ........................ 7
REF ................. ........................ 8
biopsy?............. ........................ 1
tumor removal? .. ........................ 1
pathology sample tested?................ 1
REF ................. ........................ 7
DK .................. ........................ 8

[IF DOCTOR’S FIRST NAME IS NOT BLANK OR ‘NA’, ASK:]
MR4B. Just to confirm, this was a pathologist?
IF NECESSARY, PROBE: What is [Dr. NAME /
this doctor]’s specialty?

[IF DOCTOR’S FIRST NAME IS NOT BLANK OR ‘NA’, ASK:]
MR4C. Is [Dr. NAME/this doctor] in a group practice,
that is, do other doctors practice at the same office,
or is [Dr. NAME/this doctor] part of a
medical facility or HMO?

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MR4aF. ___________________________
NA ............. [MR4aH] ................. NA
DK ............. [MR4aL] ................... 7
REF ............ [MR4aL] ................... 8
MR4aL. ___________________________
DK ............. [MR4aH] ................... 7
REF ............ [MR4aH] ................... 8

PRIMARY CARE........................... 01
INTERNAL MEDICINE .................... 02
SURGEON ................................. 03
ONCOLOGIST............................. 04
PATHOLOGIST ........................... 05
RADIOLOGIST ............................ 06
OTHER .................................... 07
SPECIFY: ______________________
REF ........................................ 97
DK ......................................... 98

YES, GROUP................................ 1
NO, SOLO................................... 2
REF .......................................... 7
DK ........................................... 8

Form #: 32
Version #: 01 (V. date 11/19/08)

MR4D. What is the street address of [Dr. NAME/
FACILITY]?

MR4dStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR4dStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [Dr. NAME/ FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [Dr. NAME/ FACILITY]?

MR4dCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [Dr. NAME/
FACILITY]?

MR4dState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [Dr. NAME/FACILITY]?

MR4dZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR4E IF STREET ADDRESS = DK:]
MR4E. What is the nearest cross street or main
intersection to [Dr. NAME/ FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR4F. What is the telephone number for [Dr. NAME/
FACILITY]?

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MR4FArea.
REF.................
DK ..................
MR4FPref.
REF.................
DK ..................
MR4FLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

[IF MR1B, MR2B, MR3B AND MR4B NOT = RADIOLOGIST, ASK:]
MR5. Was there a radiologist or radiology center involved YES .......................................... 1
in your breast cancer diagnosis or treatment?
NO....................... [MR6] ............ 2
MR5A. What is the first and last name of your
radiologist?
[RECORD RADIOLOGIST’S FIRST NAME AND LAST
NAME. IF NO SPECIFIC DOCTOR, ENTER “NA.”]

MR5aH. What is the name of the health care facility
of your radiologist?
[IF NO FACILITY NAME ENTER ‘NA’]
MR5A1.Was this where you had a…

MR5aF. ___________________________
NA ............. [MR5aH] ................. NA
DK ............. [MR5aL] ................... 7
REF ............ [MR5aL] ................... 8
MR5aL. ___________________________
DK ............. [MR5aH] ................... 7
REF ............ [MR5aH] ................... 8
_________________________________
NA .................. ...................... NA
DK .................. ........................ 7
REF ................. ........................ 8
biopsy?............. ........................ 1
tumor removal? .. ........................ 1
pathology sample tested?................ 1
REF ................. ........................ 7
DK .................. ........................ 8

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR5B. Just to confirm, this was a radiologist?
IF NECESSARY, PROBE: What is [Dr. NAME /
this doctor]’s specialty?

PRIMARY CARE........................... 01
INTERNAL MEDICINE .................... 02
SURGEON ................................. 03
ONCOLOGIST............................. 04
PATHOLOGIST ........................... 05
RADIOLOGIST ............................ 06
OTHER .................................... 07
SPECIFY: ______________________
REF ........................................ 97
DK ......................................... 98

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR5C. Is [Dr. NAME/this doctor] in a group practice,
YES, GROUP................................ 1
that is, do other doctors practice at the same office, NO, SOLO................................... 2
or is [Dr. NAME/this doctor] part of a
REF .......................................... 7
medical facility or HMO?
DK ........................................... 8

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Form #: 32
Version #: 01 (V. date 11/19/08)

MR5D. What is the street address of [Dr. NAME/
FACILITY]?

MR5dStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR5dStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [Dr. NAME/ FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [Dr. NAME/ FACILITY]?

MR5dCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [Dr. NAME/
FACILITY]?

MR5dState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [Dr. NAME/FACILITY]?

MR5dZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR5E IF STREET ADDRESS = DK:]
MR5E. What is the nearest cross street or main
intersection to [Dr. NAME/ FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR5F. What is the telephone number for [Dr. NAME/
FACILITY]?

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MR5FArea.
REF.................
DK ..................
MR5FPref.
REF.................
DK ..................
MR5FLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

[BEGIN REPEATING RECORD]
MR6. Were there any other doctors or health care facilities YES ........................................ 1
involved in your breast cancer diagnosis or treatment? NO..................... [MR7] ............ 2
MR6A. What is the first and last name of your doctor?
[RECORD OTHER DOCTOR’S FIRST NAME AND
LAST NAME. IF NO SPECIFIC DOCTOR, ENTER
“NA.”]

MR6aH. What is the name of the health care facility
of your doctor?
[IF NO FACILITY NAME ENTER ‘NA’]
MR6A1.Was this where you had a…

MR6aF. ___________________________
NA ............. [MR6aH] ................. NA
DK ............. [MR6aL] ................... 7
REF ............ [MR6aL] ................... 8
MR6aL. ___________________________
DK ............. [MR6aH] ................... 7
REF ............ [MR6aH] ................... 8
_________________________________
NA .................. ...................... NA
DK .................. ........................ 7
REF ................. ........................ 8
biopsy?............. ........................ 1
tumor removal? .. ........................ 1
pathology sample tested?................ 1
REF ................. ........................ 7
DK .................. ........................ 8

[ASK MR6A2 IF MR6A1 IS ALL NO, ELSE GO TO MR6B]
MR6A2. What medical or diagnostic services
did you receive [from Dr. NAME / at
FACILITY] for your breast cancer?
[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR6B. What is [Dr. NAME/this doctor]’s specialty?

RECORD VERBATIM: ________________
_________________________________
_________________________________

PRIMARY CARE........................... 01
INTERNAL MEDICINE .................... 02
SURGEON ................................. 03
ONCOLOGIST............................. 04
PATHOLOGIST ........................... 05
RADIOLOGIST ............................ 06
OTHER .................................... 07
SPECIFY: ______________________
REF ........................................ 97
DK ......................................... 98

[IF DOCTOR’S FIRST NAME IS NOT ‘NA’, ASK:]
MR6C. Is [Dr. NAME/this doctor] in a group practice,
YES, GROUP................................ 1
that is, do other doctors practice at the same office, NO, SOLO................................... 2
or is [Dr. NAME/this doctor] part of a
REF .......................................... 7
medical facility or HMO?
DK ........................................... 8
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Form #: 32
Version #: 01 (V. date 11/19/08)

MR6D. What is the street address of [Dr. NAME/
FACILITY]?

MR6dStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR6dStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [Dr. NAME/ FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [Dr. NAME/ FACILITY]?

MR6dCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [Dr. NAME/
FACILITY]?

MR6dState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [Dr. NAME/FACILITY]?

MR6dZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR6E IF STREET ADDRESS = DK:]
MR6E. What is the nearest cross street or main
intersection to [Dr. NAME/ FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR6F. What is the telephone number for [Dr. NAME/
FACILITY]?

[END REPEATING RECORD]

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MR6FArea.
REF.................
DK ..................
MR6FPref.
REF.................
DK ..................
MR6FLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

[IF MR1A1, MR2A1, MR3A1, MR4A1, MR5A1, MR6A1 NOT = LOCATION OF BIOPSY, ASK:]
MR7. Where was the biopsy done?
______________________________
[ENTER NAME OF HEALTH CARE FACILITY]
REF..............[MR8] ___________ 7
DK ...............[MR8] ___________ 8
MR7A. What is the street address of [FACILITY]?

MR7aStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR7aStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [FACILITY]?

MR7aCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [FACILITY]?

MR7aState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [FACILITY]?

MR7aZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR7B IF STREET ADDRESS = DK:]
MR7B. What is the nearest cross street or main
intersection to [FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR7C. What is the telephone number for [FACILITY]?

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MR7cArea.
REF.................
DK ..................
MR7cPref.
REF.................
DK ..................
MR7cLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

[IF MR1A1, MR2A1, MR3A1, MR4A1, MR5A1, MR6A1 NOT = LOCATION OF TUMOR REMOVAL, ASK:]
MR8. In what medical facility was the tumor
______________________________
removed?
REF ............. [MR9]................ 7
[ENTER NAME OF HEALTH CARE FACILITY]
DK .............. [MR9]................ 8
MR8A. What is the street address of [FACILITY]?

MR8aStr1. _____________________
REF................. ....................7
DK .................. ....................8

[IF NO ADDITIONAL ADDRESS INFO PRESS [ENTER]
TO CONTINUE]

MR8aStr2. _____________________
REF................. ....................7
DK .................. ....................8

What is the city of [FACILITY]?
[IF CITY UNKNOWN, ASK:] What is the largest
city or town near [FACILITY]?

MR8aCity. _____________________
REF................. ....................7
DK .................. ....................8

What is the name of the state of [FACILITY]?

MR8aState.
[USE STATE LOOKUP]
REF................. ....................7
DK .................. ....................8

What is the zip code of [FACILITY]?

MR8aZip.
|__|__|__|__|__|
REF................. ....................7
DK .................. ....................8

[ASK MR8B IF STREET ADDRESS = DK:]
MR8B. What is the nearest cross street or main
intersection to [FACILITY]?

______________________________
REF................. ....................7
DK .................. ....................8

MR8C. What is the telephone number for [FACILITY]?

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MR8cArea.
REF.................
DK ..................
MR8cPref.
REF.................
DK ..................
MR8cLine.
REF.................
DK ..................

|__|__|__|
....................7
....................8
|__|__|__|
....................7
....................8
|__|__|__|__|
....................7
....................8

Form #: 32
Version #: 01 (V. date 11/19/08)

MR9.

We also would like to get a sample of your breast tissue that the pathologist may have saved.
The pathologist will also require a signed authorization form to ensure that we have your
permission to obtain some of your tissue samples. These samples will provide further
information about specific breast cancer features and will be used for research purposes only.
We will store your samples carefully and will return what we have to you or your doctor if you
request it.
We will send you the form asking your permission to obtain some of your archived tumor
tissue with additional information explaining how it will be used and stored. You will have
the opportunity to read the authorization form and decide for yourself if you would like to
sign it. We will not contact your pathologist to ask for samples unless you give us permission
to do so by signing the authorization form.
[ANSWER QUESTIONS, REFERRING TO FAQS ABOUT TISSUE SAMPLES AND HIPAA]
CONTINUE ......... [CN1] ............ 1

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Form #: 32
Version #: 01 (V. date 11/19/08)

CN: CONCLUSION
[IF PATI(NT PROVIDED DOCTOR INFORMATION, ASK:]
CN1. We will mail you a packet in about a week containing the Medical Record and Tissue
Authorization forms and instructions for completing them. We ask that you follow the
instructions carefully and return the signed forms to us in the enclosed postage-paid envelope
as soon as you can.
CONTINUE .... [CN1a]................ 1
[ASK CN1a IF IN5 = 1, ELSE GO TO CN1c:]
CN1a. You mentioned earlier that you have a
copy of your pathology records. Would you
be willing to send us a copy of the report
so we can confirm the details of your
breast cancer diagnosis?

YES................. .................... 1
NO ............. [CN1c]................ 2

[ASK CN1b IF CN1a = 1, ELSE GO TO CN1c:]
CN1b. Thank you. Please make a copy of your pathology results and enclose it in the postagepaid return envelope we will provide.
CONTINUE ............. [CN1c]................ 1
CN1c. If you have any questions, please call the Sister Study toll-free number (1-877-4SISTER)
and follow directions for enrolled women.
CONTINUE .............. [END] ................ 1
[IF PATI(NT REFUSED TO PROVIDE INFORMATION ON DOCTORS OR MEDICAL FACILITIES BUT
AGREED TO LET US CALL BACK, ASK:]
CN2. We will mail you information about medical record authorization forms and then contact you
again in a few weeks. If you have any questions, please call the Sister Study toll-free number
(1-877-4SISTER) and follow directions for enrolled women.
CONTINUE ................. .................... 1
[GO TO IN7 FOR RE-CONTACT AFTER APPROXIMATELY 14 DAYS IF PATI(NT DOES NOT
RETURN COMPLETED FORMS]
[IF PATI(NT REFUSED TO PROVIDE INFORMATION ON DOCTORS OR MEDICAL FACILITIES BUT DID
NOT AGREE TO LET US CALL BACK, ASK]
CN3. We will mail you information about medical record authorization forms for you to review. If
you change your mind about giving us information on the doctors or medical facilities involved
in your breast cancer diagnosis and treatment, please call the Sister Study toll-free number
(1-877-4SISTER) and follow directions for enrolled women.
CONTINUE .............. [END] ................ 1
44 of 44
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Sister Study - Breast Cancer Follow-up, Authorization Packet Cover Letter

DATE
FirstName LastName
Address 1
Address 2
City, State, Zip
Dear Ms. [LastName]:
Thank you for talking with a Sister Study staff member about your breast cancer diagnosis and treatment.
During the telephone call, [IF R HAS A COPY OF HER PATHOLOGY REPORT AND SAID SHE WAS WILLING
TO PROVIDE A COPY: you mentioned you were willing to send us a copy of the pathology report related to
your breast cancer diagnosis. Please make a copy of your report and send it to us in the enclosed postage-paid
envelope (The Sister Study, 1009 Slater Road, Suite 120, Durham, NC 27703). We also /ELSE: we] discussed
the importance of collecting additional information and samples. In the enclosed folder you will find several
important documents for you to sign that will give us permission to obtain information from your medical providers
about your breast cancer diagnosis and treatment. Please return these documents to the Sister Study office.
With your permission, we will:
- request information about your breast cancer diagnosis and treatment. You have already shared
some of this information, but your doctor and medical record are the best sources of detailed medical
information about specific features of your breast cancer and treatment.
-

- request some of the breast tissue samples that were saved after your biopsy or surgery. With
these samples, we can test for molecular markers that may help us understand the causes and
characteristics of this disease. We will protect some of your samples for 10 years, and return what we
have to your doctors if they are needed later for your care.
It is up to you to decide if you will give us permission to request information and samples from your medical
providers. You can refuse all or part of that request and it will not affect your participation in the rest of the
Sister Study. However, the information about your diagnosis and treatment is especially important. Any medical
provider has the right to refuse to participate, just as you do. However, in our experience, most doctors and
hospitals are very willing to provide information if they know the patient has given her permission.
We have also enclosed some answers to questions you may have about our request. If you have any other
questions or want to speak with someone, please call the Sister Study Helpdesk at 1-877-474-7837. As we
promised when you joined the Sister Study, we will take precautions to keep all of your personal information
safe, private and confidential.
Thank you again for your participation in this research. I wish you a complete recovery and future good health.
Sincerely,

Dale P. Sandler, Ph.D.
Principal Investigator

for you to keep

complete and return

this pocket contains materials

this pocket contains materials for you to

Authorization Packet

Authorization Packet

to the Sister Study

1-877-4SISTER

WWW.SISTERSTUDY.ORG

Authorization Packet

START HERE - HOW TO COMPLETE YOUR SISTER STUDY
AUTHORIZATION FORMS
This folder contains authorization forms and other materials related to your breast cancer
diagnosis. Please read these instructions carefully before proceeding.
The OHIW VLGH of the folder contains
materials for you to complete and return
to the Sister Study:

The ULJKW VLGH of the folder contains
materials for you to keep:



AUTHORIZATION FOR RELEASE OF
MEDICAL RECORD INFORMATION – Read
carefully, sign and date.



AUTHORIZATION FOR RELEASE OF
MEDICAL RECORD INFORMATION – Keep
this copy for your records.



AUTHORIZATION FOR RELEASE OF
PATHOLOGY SPECIMENS – Read
carefully, sign and date.



AUTHORIZATION FOR RELEASE OF
PATHOLOGY SPECIMENS – Keep this
copy for your records.



3529,'(5$ND MEDICAL&$5()$&,/,7<
LIST – Keep this copyfor your records.



FREQUENTLY ASKED QUESTIONS – Refer
to this booklet if you have questions.
Keep this for your records.



PR29,'(5$ND MEDICAL&$5()$&,/,7<
LIST – Review theinformation listed.
Fill in any missing orincorrect
information. Check Yes orNo for each
Srovider to authorize thedoctor or
treatment facilities to providemedical
information to the Sister Study.


If you have a copy of your pathology
report and are willing to share it with
us, please make a copy and enclose it
as well. This will help us confirm the
details of your breast cancer diagnosis.



SELF-ADDRESSED, POSTAGE-PAID
ENVELOPE – After you have completed
the items above, place them in the
envelope, seal and return to the Sister
Study.

After we receive your signed forms, we will contact the medical providers you indicate on the
PR29,'(5 AND MEDICAL CARE FACILITY LIST.
Providers will be asked for detailed medical information about specific features of your breast
cancer and treatment or for some of the breast tissue samples that were saved after your biopsy
or surgery. Each provider will be sent a copy of the AUTHORIZATION FOR RELEASE OF MEDICAL
RECORD or the AUTHORIZATION FOR RELEASE OF PATHOLOGY SPECIMENS that you sign.
If you have any questions, please call the Sister Study toll-free at
1-877-4SISTER (1-877-474-7837). Thank you!
National Institute of Environmental Health Sciences / National Institutes of Health / U.S. Department of Health and Human Services

Page 1 of 1

12/01/2008

Form #: 06
Version #: 01 (V. Date 12/02/08)

*xxxxxxx-mrau*

OMB No. 0925-0522

SISID xxxxxxx mrau

Authorization for Release of Medical Record Information
Sister Study: Environmental and Genetic Risk Factors for Breast Cancer
Please read carefully, sign this copy, and place in the mailer to be returned to the Sister Study
Provider Name:
Street Address:
City:
Telephone:

State:

Zip:

I am voluntarily participating in the Sister Study, a nationwide study of sisters of women who had breast cancer.
The study is designed to identify risk factors for breast cancer and factors that may influence the long-term health
of women after treatment for breast cancer. The National Institute of Environmental Health Sciences, one of the
National Institutes of Health, of the U.S. Department of Health and Human Services is conducting the study.
I authorize and request that you provide the Sister Study and its staff with the medical information they request
about all health services provided to me. This authorization form covers any care I received at your facility. It
also covers care I received from any medical provider associated with your facility or who provided care to me in
your facility as well as any services or treatment that I received that may be in your records. The information
requested pertains to my diagnosis or treatment of breast cancer and any other relevant information.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits you from releasing my
information without my authorization. This form (or a photocopy of this form) gives you my authorization. I have
signed this form voluntarily, with the understanding that my decision to sign or not to sign the form will have no
effect on my eligibility for treatment, payment, enrollment, or eligibility for any benefits to which I am entitled.
The Sister Study and its staff will use this information to supplement the information I have already given for the
Sister Study. Once my information is released to the study, it is no longer covered by HIPAA, but is covered by
the Public Health Service Act, which prohibits the release of information that would identify me or my medical
providers outside the sponsoring agency and its contractors without my permission or that of my medical
providers.
I authorize the study to use information I have given in the study to help you identify my records. I can revoke this
authorization at any time by contacting a study representative in writing or by telephone at the address and
telephone number listed below. Otherwise, this authorization expires 30 months from the date of signature.
Patient Name:
Date of Birth:
MONTH

DAY

YEAR

Other Names under Which Records May be Filed:

Social Security Number:

|__|__|__| – |__|__| – |__|__|__|__|

Signature:

Date:

Proxy Signature:

Relationship to Patient:

Reason for Proxy:

Patient deceased
Patient incapacitated

The Sister Study, 1009 Slater Road, Suite 120, Durham, NC 27703
phone: 1-877-4SISTER (1-877-474-7837); email: info@sisterstudy.org

Form #: 06
Version #: 01 (V. Date 12/02/08)

*xxxxxxx-mrau*

OMB No. 0925-0522

SISID xxxxxxx mrau

Authorization for Release of Medical Record Information
Sister Study: Environmental and Genetic Risk Factors for Breast Cancer
Please return the copy you sign. Keep this copy for your records.
Provider Name:
Street Address:
City:
Telephone:

State:

Zip:

I am voluntarily participating in the Sister Study, a nationwide study of sisters of women who had breast cancer.
The study is designed to identify risk factors for breast cancer and factors that may influence the long-term health
of women after treatment for breast cancer. The National Institute of Environmental Health Sciences, one of the
National Institutes of Health, of the U.S. Department of Health and Human Services is conducting the study.
I authorize and request that you provide the Sister Study and its staff with the medical information they request
about all health services provided to me. This authorization form covers any care I received at your facility. It
also covers care I received from any medical provider associated with your facility or who provided care to me in
your facility as well as any services or treatment that I received that may be in your records. The information
requested pertains to my diagnosis or treatment of breast cancer and any other relevant information.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits you from releasing my
information without my authorization. This form (or a photocopy of this form) gives you my authorization. I have
signed this form voluntarily, with the understanding that my decision to sign or not to sign the form will have no
effect on my eligibility for treatment, payment, enrollment, or eligibility for any benefits to which I am entitled.
The Sister Study and its staff will use this information to supplement the information I have already given for the
Sister Study. Once my information is released to the study, it is no longer covered by HIPAA, but is covered by
the Public Health Service Act, which prohibits the release of information that would identify me or my medical
providers outside the sponsoring agency and its contractors without my permission or that of my medical
providers.
I authorize the study to use information I have given in the study to help you identify my records. I can revoke this
authorization at any time by contacting a study representative in writing or by telephone at the address and
telephone number listed below. Otherwise, this authorization expires 30 months from the date of signature.
Patient Name:
Date of Birth:
MONTH

DAY

YEAR

Other Names under Which Records May be Filed:

Social Security Number:

|__|__|__| – |__|__| – |__|__|__|__|

Signature:

Date:

Proxy Signature:

Relationship to Patient:

Reason for Proxy:

Patient deceased
Patient incapacitated

The Sister Study, 1009 Slater Road, Suite 120, Durham, NC 27703
phone: 1-877-4SISTER (1-877-474-7837); email: info@sisterstudy.org

Form #: 07
Version #: 01 (V. Date 12/02/08)

*xxxxxxx-ptau*

OMB No. 0925-0522

SISID xxxxxxx ptau

Authorization for Release of Pathology Specimens
Sister Study: Environmental and Genetic Risk Factors for Breast Cancer
Please read carefully, sign this copy, and place in the mailer to be returned to the Sister Study
Provider Name:
Street Address:
City:
Telephone:

State:

Zip:

I am voluntarily participating in the Sister Study, a nationwide study of sisters of women who had breast cancer.
The study is designed to identify risk factors for breast cancer and factors that may influence the long-term health
of women after treatment for breast cancer. The National Institute of Environmental Health Sciences, one of the
National Institutes of Health, of the U.S. Department of Health and Human Services is conducting the study.
I authorize and request that you provide the Sister Study and its staff with some of the pathology specimens
pertaining to my diagnosis of breast cancer. The Sister Study is not asking for all of my tissue because there may
be medical uses for my tissue in the future. They will use up some but not all of the tumor tissue you send them,
and will keep remaining tissue in a secure place for at least the next 10 years. If remaining tissue is needed back
during that time, they will send it to me or to anyone I name, if requested in writing.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits you from releasing my
information without my authorization. This form (or a photocopy of this form) gives you my authorization. I have
signed this form voluntarily, with the understanding that my decision to sign or not to sign the form will have no
effect on my eligibility for treatment, payment, enrollment, or eligibility for any benefits to which I am entitled.
The National Institute of Environmental Health Sciences and its contractors will use these specimens to
supplement the information I have already given for the Sister Study. Once my information is released to the
study, it is no longer covered by HIPAA, but is covered by the Public Health Service Act, which prohibits the
release of information that would identify me or my medical providers outside the sponsoring agency and its
contractors without my permission or that of my medical providers.
I authorize the study to use information I have given in the study to help you identify my specimens. I can revoke
this authorization at any time by contacting a study representative in writing or by telephone at the address and
telephone number listed below. Otherwise, this authorization to obtain pathology specimens expires 30 months
from the date of signature.
Patient Name:
Date of Birth:
MONTH

DAY

YEAR

Other Names under Which Records May be Filed:

Social Security Number:

|__|__|__| – |__|__| – |__|__|__|__|

Signature:

Date:

Proxy Signature:

Relationship to Patient:

Reason for Proxy:

Patient deceased
Patient incapacitated

The Sister Study, 1009 Slater Road, Suite 120, Durham, NC 27703
phone: 1-877-4SISTER (1-877-474-7837); email: info@sisterstudy.org

Form #: 07
Version #: 01 (V. Date 12/02/08)

*xxxxxxx-ptau*

OMB No. 0925-0522

SISID xxxxxxx ptau

Authorization for Release of Pathology Specimens
Sister Study: Environmental and Genetic Risk Factors for Breast Cancer
Please return the copy you sign. Keep this copy for your records.
Provider Name:
Street Address:
City:
Telephone:

State:

Zip:

I am voluntarily participating in the Sister Study, a nationwide study of sisters of women who had breast cancer.
The study is designed to identify risk factors for breast cancer and factors that may influence the long-term health
of women after treatment for breast cancer. The National Institute of Environmental Health Sciences, one of the
National Institutes of Health, of the U.S. Department of Health and Human Services is conducting the study.
I authorize and request that you provide the Sister Study and its staff with some of the pathology specimens
pertaining to my diagnosis of breast cancer. The Sister Study is not asking for all of my tissue because there may
be medical uses for my tissue in the future. They will use up some but not all of the tumor tissue you send them,
and will keep remaining tissue in a secure place for at least the next 10 years. If remaining tissue is needed back
during that time, they will send it to me or to anyone I name, if requested in writing.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits you from releasing my
information without my authorization. This form (or a photocopy of this form) gives you my authorization. I have
signed this form voluntarily, with the understanding that my decision to sign or not to sign the form will have no
effect on my eligibility for treatment, payment, enrollment, or eligibility for any benefits to which I am entitled.
The National Institute of Environmental Health Sciences and its contractors will use these specimens to
supplement the information I have already given for the Sister Study. Once my information is released to the
study, it is no longer covered by HIPAA, but is covered by the Public Health Service Act, which prohibits the
release of information that would identify me or my medical providers outside the sponsoring agency and its
contractors without my permission or that of my medical providers.
I authorize the study to use information I have given in the study to help you identify my specimens. I can revoke
this authorization at any time by contacting a study representative in writing or by telephone at the address and
telephone number listed below. Otherwise, this authorization to obtain pathology specimens expires 30 months
from the date of signature.
Patient Name:
Date of Birth:
MONTH

DAY

YEAR

Other Names under Which Records May be Filed:

Social Security Number:

|__|__|__| – |__|__| – |__|__|__|__|

Signature:

Date:

Proxy Signature:

Relationship to Patient:

Reason for Proxy:

Patient deceased
Patient incapacitated

The Sister Study, 1009 Slater Road, Suite 120, Durham, NC 27703
phone: 1-877-4SISTER (1-877-474-7837); email: info@sisterstudy.org

*xxxxxxx-drls*

Form #: 08

SISID xxxxxxx drls

Version #: 01 (V. date 12/02/08)

3URYLGHUDnd Medical Care Facility List

Please complete and return this form to the Sister Study with the enclosed authorization forms

Check Yes or No for each Provider

Type of Medical
Provider

Main doctor or facility
responsible for breast
cancer diagnosis and
treatment
Oncologist or oncology
center

Please provide or correct
the information displayed
below
Name:
Address:
Telephone:
Name:
Address:
Telephone:

Surgeon or surgery
center

Name:
Address:
Telephone:

Pathologist

Name:
Address:
Telephone:

Therapeutic
Radiologist or
radiology center
Other doctors or
facilities involved in
your breast cancer
diagnosis and
treatment

Name:
Address:

,

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

,

,

,

Telephone:

Name:
Address:

Telephone:

Telephone:

 Yes

Name:
Address:

Name:
Address:

 No

,

Telephone:

 Yes

Telephone:

Name:
Address:

I authorize and request that this doctor or
treatment facility provide the Sister Study
and its staff with the medical information
they request about all health services
provided to me.

,

,

,

,

*xxxxxxx-drls*

Form #: 08

SISID xxxxxxx drls

Version #: 01 (V. date 12/02/08)

PURYLGHUDnd Medical Care Facility List
Please return the copy you sign. Keep this copy for your records.

Check Yes or No for each Provider

Type of Medical
Provider

Main doctor or facility
responsible for breast
cancer diagnosis and
treatment
Oncologist or oncology
center

Please provide or correct
the information displayed
below
Name:
Address:
Telephone:
Name:
Address:
Telephone:

Surgeon or surgery
center

Name:
Address:
Telephone:

Pathologist

Name:
Address:
Telephone:

Therapeutic
Radiologist or
radiology center
Other doctors or
facilities involved in
your breast cancer
diagnosis and
treatment

Name:
Address:

,

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

 Yes

 No

,

,

,

Telephone:

Name:
Address:

Telephone:

Telephone:

 Yes

Name:
Address:

Name:
Address:

 No

,

Telephone:

 Yes

Telephone:

Name:
Address:

I authorize and request that this doctor or
treatment facility provide the Sister Study
and its staff with the medical information
they request about all health services
provided to me.

,

,

,

,

Question Section

Page

General information about the Sister Study and this request ........ 2-3
How is my privacy protected? ............................................. 3-5
Tell me more about medical records and tissue specimens ........... 5-8
How do I find out more? ........................................................ 9

National Institute of Environmental Health Sciences / National Institutes of Health / U.S. Department of Health and Human Services

V1. 12/02/08

ANSWERS TO YOUR QUESTIONS

ANSWERS TO YOUR QUESTIONS
ABOUT MEDICAL RECORDS AND
TISSUE SPECIMENS

General Information about the Sister Study and This Request
What is the Sister Study?
The Sister Study is the only long-term study in the United States and Puerto Rico of women
ages 35 to 74 whose sisters had breast cancer. This study is conducted by the National
Institute of Environmental Health Sciences (NIEHS), one of the National Institutes of Health.
The study is following 50,000 women for at least 10 years to learn how environment and
genes may affect the chances of getting breast cancer.

What will the Sister Study tell us?
Researchers believe the Sister Study will help us better understand reasons women get
breast cancer, especially reasons that concern environment and genes. With the new
information about your breast cancer diagnosis and treatment, researchers hope to better
understand how environment and genes affect risk for different types of breast cancer.
They will also learn how these factors affect health and survival after a diagnosis.
Knowledge gained from the Sister Study will be used to develop recommendations for
preventing breast cancer in the future and promoting good health for women.

Who is running the study?
Researchers at the National Institute of Environmental Health Sciences (NIEHS) are running
the study. NIEHS is one of the National Institutes of Health, part of the Department of
Health and Human Services. The web site for NIEHS is http://www.niehs.nih.gov.
The Investigators are —
Dale P. Sandler, PhD
Chief of Epidemiology Branch
Clarice Weinberg, PhD
Chief of Biostatistics Branch
Lisa DeRoo, PhD
Epidemiology Branch

I have been diagnosed with breast cancer. Will I continue to be part of the
Sister Study?
Yes. When a participant develops breast cancer, we still want to follow her health over
time to learn about factors that may contribute to her healthy survival. We hope you will
participate for the full length of the study. By continuing to follow women diagnosed with
breast cancer we can learn if environmental, lifestyle, and genetic factors influence
treatment outcomes, survival, and quality of life following a diagnosis of breast cancer. We
can also learn about other aspects of women’s health.

Who makes sure this study is safe and scientifically sound?
Research funded by the federal government is carefully reviewed and monitored. This study
has been reviewed for its scientific quality by experts in the field (mainly university
2

scientists) and is overseen by a Scientific Advisory Board made up of scientists and
community representatives. In addition, the Institutional Review Board (IRB) of the NIEHS
reviews the study, identifying issues and concerns, and works with the investigators as
needed to improve the study. The NIEHS IRB is diverse and includes ethicists, lawyers,
physicians, scientists from NIEHS, as well as other scientists and members of the local
community. Studies like the Sister Study must be reviewed and approved by the IRB before
they can begin and then they are reviewed annually.
All institutions, including the National Institutes of Health (NIH), that receive funds from the
U.S. Department of Health and Human Services to conduct or support research with human
subjects must follow specific rules and are guided by ethical principles of a document known
as The Belmont Report, which you can read at the website
http://ohsr.od.nih.gov/guidelines/belmont.html. NIH has developed a system of education
and approval procedures to assist investigators in understanding and complying with wellestablished ethical and regulatory requirements. The investigators and staff who are
conducting the Sister Study receive ongoing education and monitoring to ensure that these
requirements are fulfilled. If you would like more information on this important topic,
please visit the NIH website at http://ohsr.od.nih.gov/info.

Who is collecting the data for NIEHS?
Social and Scientific Systems, Inc., a professional services research firm specializing in
health studies and epidemiologic research, works closely with NIEHS investigators to recruit
participants, collect data, and manage the day-to-day activities of the study. More
information can be found at www.s-3.com.

How is My Privacy Protected?
Will my information be kept confidential? How will this be done?
All of the Sister Study staff sign confidentiality forms and undergo training in research
ethics. We have put in place several protections for the privacy of your data. When your
data are collected, they are labeled with an ID number. After your data are collected, your
samples, questionnaires, and interview data are stored separately from all personal
identifiers, such as your name, address, and telephone number. Your personal contact
information is kept in separate files accessible only to Sister Study staff on a need-to-know
basis.
The Sister Study has received a Certificate of Confidentiality that helps us protect the
confidentiality of your data against compulsory legal demands (e.g., court orders and
subpoenas) that seek the name or other identifying characteristics of a research subject.

What is a Certificate of Confidentiality and what does this mean for me?
A Certificate of Confidentiality helps researchers protect the privacy of subjects in
biomedical, behavioral, clinical, or other research projects against compulsory legal
demands (e.g., court orders and subpoenas) that seek the name or other identifying
3

characteristics of a research subject. A Certificate of Confidentiality can protect researchers
from being forced to give out information that could identify you.

What protection does a Certificate of Confidentiality provide?
Confidentiality Certificates are issued by the U.S. Department of Health and Human Services
to provide privacy protection to research subjects. These certificates are authorized by law
in provision 301(d) of the Public Health Services Act (42 U.S.C. Section 241(d)). A
Certificate can be used by the researcher to avoid compelled "involuntary disclosure" (e.g.,
subpoenas) of identifying information about a research subject.

What protection does a Certificate NOT provide?
A Certificate of Confidentiality does NOT prevent researchers from voluntarily disclosing
information about a participant if it is considered necessary to protect a participant or
someone else from serious harm, as in cases of child abuse. A Certificate of Confidentiality
also does not prevent you or a member of your family from voluntarily releasing information
about yourself or your involvement in this research. If an insurer or employer learns about
your participation from you, and you consent in writing to having information about you
released, then we cannot use the Certificate of Confidentiality to withhold this information.
This means that you and your family must also actively protect your own privacy. We will
keep your participation in this research study confidential to the extent permitted by law.
However, it is possible that other people may become aware of your participation in this
study without your permission, for example, if it is required by the Food and Drug
Administration (FDA), members of Congress, law enforcement officials, or other authorized
people.

How long is my information protected under the terms of the Certificate?
The Certificate covers the collection of sensitive research information for a defined time
period (the term of the project); however, personally identifiable information obtained
under protection of a Certificate is protected forever. In other words, we researchers can
collect new data under the Certificate only during the agreed upon length of the study. But
your privacy is protected even after the study has ended.

Will my insurance company or employer obtain the information I give you as part
of the study?
No, we will not provide any study information to insurance companies or employers, as it is
strictly protected by confidentiality rules. However, this does not prevent you or a member
of your family from voluntarily releasing information about yourself or your involvement in
this research should you choose to do so on your own.

Why are you asking for my Social Security Number?
Social Security numbers are very important in a long-term follow-up study. We will use your
Social Security number to link to national databases to obtain necessary medical and vital
status information and to help us locate you if we lose contact. Your Social Security number
also helps your health care providers accurately identify your medical records. We recognize
that your Social Security number is private and many people are worried about sharing this
number. We will make sure that only key study personnel have access to your Social Security
4

number, and then only for purposes directly related to the Sister Study. If you are still
worried about providing your SSN, you may simply give the last four digits or omit it
altogether even though this may make it harder for us to be sure we get the right records.

Tell Me More about Medical Records and Tissue Specimens
I’ve already given you information about my diagnosis and treatment. Why do
you need to contact my health care providers?
We contact health care providers for valuable additional information about your breast
cancer diagnosis and treatment. Specific features of your breast cancer such as cell type,
behavior, size, and tumor location may hold clues to the causes we are trying to find. The
best source of accurate information on specific breast cancer features and treatment is the
medical record. While some women have this information, others may not. It is important
to collect it the same way for all women.

You are requesting permission to obtain medical information and stored breast
tissue specimens from my medical care providers. What if I would like to give
permission for only one of these?
It is up to you whether you want to give us permission to obtain the information and samples
we request. You may refuse all or part of our request. Your decision will not affect your
participation in the rest of the Sister Study. If you are willing to provide the medical
information but not the permission for tissue samples (or vice versa), the information you
provide will still be helpful. However, having both sources of information would give the
most complete picture of your breast cancer diagnosis, tumor characteristics and
treatments, and would be most valuable to us in studying both the causes of breast cancer
and factors that affect long-term health after a diagnosis.

What if I do not want my personal health information to be used in this research
study?
You may refuse to give permission to obtain your medical information or change your mind
later. Your decision will not affect your participation in the rest of the Sister Study.
However, the purpose of the study is to learn how your health changes over the course of
the years you are enrolled in the study. Information from your medical record is very
important to us for understanding the details of your breast cancer diagnosis and treatment.
We value your participation in the study, and giving us this additional information makes the
other information you are providing even more valuable for our efforts to understand the
causes of breast cancer.

What personal health information am I giving you permission to get?
We will ask for a copy of the diagnostic pathology report and for information about your
diagnosis and treatment for breast cancer, including the results of physical examinations,
medical history, lab tests, biopsies, surgeries, chemotherapy, radiation, and information
from follow-up visits. This information, along with environmental and lifestyle information
you provide separately will help us understand breast cancer risk factors as well as factors
that affect outcomes after breast cancer diagnosis and treatment.
5

How will you use the details of my diagnosis?
We will use information from the medical record to classify your breast cancer into subtypes
so that we can identify environmental and genetic risk factors that are specific for different
types of breast cancer. Since most women with breast cancer can expect to live a long time
and may have a range of health concerns, we will also use this information to study possible
long-term influences on health.

How will you use the information on my treatment?
In order to determine if environmental factors and lifestyle influence how women do after a
diagnosis of breast cancer, we have to take into account the influence of different
treatments that women receive.

Why do you need the authorization form?
Health care information is private. Your providers cannot release information about you to a
study like the Sister Study without your written permission. In 2003, a federal law called the
Health Insurance Portability and Accountability Act (HIPAA for short) created new and
stronger standards for protecting health care information. Your providers may have told you
about some of these new requirements. One section of the law sets guidelines for the
authorization forms that must be signed to allow a provider to release health care
information. The Sister Study authorization form follows these guidelines.

How will you contact my doctor or hospital?
Providers will be contacted by telephone and then by mail with a copy of your signed
authorization form and another form they will use to give us the information we need.

My providers are very busy. Isn’t this a bother to them?
Your signature on the authorization form allows your doctor or hospital to participate in the
study if they choose. Most health care providers are willing to participate in important
research like the Sister Study. Usually, an office staff person can fill out the form.

What information will you give to my doctor about me?
To allow medical staff to find your records, we will give them your name, date of birth,
approximate date of diagnosis and the signed authorization form. We may also share other
information such as your Social Security number, treatment or your address if needed to
help a doctor or hospital find the correct records.

Will this affect my Medicare, Medicaid, VA benefits, or any other public
assistance I am receiving?
No. Signing or not signing this authorization form will not affect your eligibility for any
program benefits.

6

Will this affect my medical care?
No. Signing or not signing this authorization form will not affect your current or future
medical care.

Will my doctor bill me for the time he or she spent participating in the Sister
Study?
No. If a doctor or hospital has a policy of charging for the information we request, the Sister
Study will pay this charge directly. If you do receive a bill by mistake, please call the Sister
Study toll-free at 1-877-4SISTER (1-877-474-7837).

What breast tissue samples are you asking for?
When patients undergo breast biopsy or surgery, breast tissue is removed and sent to the
medical provider’s pathology department for testing and diagnosis. After that process is
finished, the remaining tissue samples are usually stored in the pathology department. We
are asking your permission to contact your provider to obtain some of the remaining tissue
samples for testing. These tests will provide further information about specific breast cancer
features.

Will my doctor need these samples for my treatment?
Your decision to allow us to use some of the remaining tissue should not affect your
treatment. While some pathology departments keep these samples indefinitely, others
routinely destroy them after a few years. We will obtain the tissue after your medical
care provider has completed testing and diagnosis. When we request samples of your tumor
tissue, we will remind the doctor to keep some of the tissue in case it is needed for your
care in the future. In addition we will not use up all of the tissue that is sent to us and we
will keep what remains for the duration of the study. If in the future you or your provider
would like your samples returned, we will be happy to return what we have. Some doctors
or hospitals have policies that will not allow them to send samples to us. If your provider
does not send us some of your samples, this will not affect your participation in the Sister
Study.

Will you provide the results of tests on my breast sample tissues to me or my
doctors?
No. Your medical care provider has already tested your tissue samples and provided the
results to you. The additional tests we will do are for research purposes only. They are not
intended to be used as diagnostic tests or to make decisions about your medical care. The
results will be combined with those of other women in the Sister Study and may not be ready
for many years. The tests will not affect your care right now, but the research results may
be helpful to women in the future.

How will my breast tissue samples be stored?
We will store your samples indefinitely in a secure building. The specimens will only have a
number attached to them. They will not contain your personal identifiers.

7

Will my breast tissue samples be shared with other researchers?
We may share portions of these samples with other researchers for related research on
women’s health. These researchers will be bound by the conditions established by the Sister
Study for the protection of your privacy and rights as a participant. We will not give other
researchers any information that would allow them to identify you. Samples will only be
shared for scientifically valid studies that meet approved standards for good science and for
protecting the rights of participants. Samples that are shared can be used only for the
specific research described in an approved research proposal and may not be used for other
purposes without approval from the Sister Study. Your tissue samples will be used only for
research and will not be sold.

What if at some point in the future my medical care providers need some of my
tumor tissue back to help them choose the best treatment for me?
We encourage you to discuss with your doctor the possible future uses of your tissue, and
the policies of the lab that now has your tissue, including how long they usually keep
specimens. We will store the tissue you authorize to be sent to us in a secure setting for at
least 10 years, being sure not to use up all of your tumor tissue. If at any time, for any
reason, you would like to have some or all of the remaining tissue returned, and you request
that in writing, we will gladly send it to you or to any recipient you name.

What if I change my mind about authorization for medical records or tissue
specimens?
You can revoke an authorization at any time by contacting the Sister Study toll-free at 1877-4SISTER (1-877-474-7837). You can contact the study by mail at the following address:
The Sister Study
1009 Slater Rd, Ste 120
Durham, NC 27703
If you decide to revoke authorization for collecting medical record information, we will stop
any efforts to contact your provider to collect this information. If your provider has already
given us information about you, we will remove the information from the study records
unless it is already incorporated into research files in which your individual information
cannot be identified even by a code number.
If you decide to revoke authorization for collection of your tissue specimens, we will stop
any efforts to contact your provider to collect the specimens. If your provider has already
sent them to us, and you request return from us in writing, we will send back all remaining
materials to the provider or institution that sent them to us, or to any person you name,
including yourself.

8

How Do I Find Out More?
Who do I contact if I have questions?
If you have any further questions or concerns about these requests, please call the Sister
Study toll-free at 1-877-4SISTER (1-877-474-7837). If you have any questions about your
rights as a research participant, please contact the NIEHS Institutional Review Board, at 1919-541-4265.

How can I learn more and have my questions answered about the Sister Study?
Please call our toll-free number, 1-877-4SISTER or email info@sisterstudy.org. A Sister Study
Help Desk staff member will answer your questions. Also, our website address is
www.sisterstudy.org.

I would like to speak to a member of the Sister Study staff about the study.
A member of our staff will be happy to answer your questions about the study. You can
reach a member of the Sister Study staff by calling our toll-free number 1-877-4SISTER and
asking for the Sister Study Help Desk, or emailing us at info@sisterstudy.org.

Is there a physician on staff who could talk to me about breast cancer?
The Sister Study does not have a physician on staff. We are not in a position to provide
medical advice. If you need to find a doctor or have questions about breast cancer, you
should contact your doctor, your local health department, the American Cancer Society, or
other organizations better qualified to provide you with breast cancer information. Links to
some of these organizations are updated regularly on our website at www.sisterstudy.org.

9

to meet both USPS regulations and automation compatibility standards.

NO POSTAGE
NECESSARY
IF MAILED
IN THE
UNITED STATES

BUSINESS REPLY
MAILDURHAM, NC
PERMIT NO. 305

FIRST-CLASS MAIL

POSTAGE WILL BE PAID BY ADDRESSEE

THE SISTER STUDY
1009 SLATER ROAD, SUITE 120
DURHAM, NC 27703-9904

AUTH

Artwork for User Defined (9" x 12")
Layout: January 10, 2008 08:11:14

Produced by US Postal Service

Telephone Prompt
Call placed to breast cancer cases who have not returned forms 4 weeks after forms are mailed
1. Hello Ms LAST NAME, my name is… and I am calling on behalf of the Sister Study. Recently you spoke
with a Sister Study staff member about your breast cancer diagnosis and treatment. We sent you some
materials to ask if you would be willing to give the Sister Study permission to contact your medical providers
to ask for additional information about your breast cancer diagnosis and treatment and to request some of the
breast tissue samples that were saved after your biopsy or surgery.
We have not yet received the forms back so we are calling to be sure you received these forms. Did you
receive the authorization forms?

1 NOT A GOOD TIME
2 YES
3 YES, ALREADY RETURNED





4 NO



DETERMINE CALLBACK TIME, RECORD IN COMMENTS
GO TO 2
Thank you very much. We'll hope to receive your forms in the
next week or so. We may call you in a couple of weeks if they
still haven't arrived. GO TO 4.
CONFIRM ADDRESS, MAKE CORRECTIONS IF NEEDED
______________________________________________

______________________________________________
Thank you, we will mail the forms in the next few days. If you have any questions when
you receive the materials, please contact the helpdesk. GO TO 4.
2. Do you have any questions about the materials you received?

1
2

YES
NO




ANSWER QUESTIONS USING FAQS. WHEN NO MORE Qs, GO TO 3
GO TO 3.

3. Please help by taking some time now to complete these forms and return them in the postage-paid envelope.

1 R WILLING



Thank you for your help. We'll hope to receive your forms in the next week or
so. We may call you in a couple of weeks if they still haven’t arrived. GO TO 4.

3 R UNWILLING



To help us understand your concerns and to improve the study procedures, can you
share with us any thoughts you had about these forms?

_________________________________________________________________________________________

It is your choice as to whether or not you want to give us permission to gather the additional information
and samples we are requesting. Your decision will not affect your participation in the rest of the Sister
Study. However, the information about your diagnosis and treatment is especially important. If you
reconsider, simply return the forms in the postage-paid envelope we provided. As we promised when you
joined the Sister Study, we will keep all of your personal information safe, private and confidential.
4. You can contact us at any time by sending an email to info@sisterstudy.org or by calling the Sister Study
helpdesk toll-free at 1-877-4SISTER (1-877-474-7837).
You can always visit our website at
www.sisterstudy.org for more news about the Sister Study. Thank you again for your ongoing contribution
to this important research. Good bye.

PROVIDER TELEPHONE SCRIPT –
CALL PLACED TO PROVIDERS OF BC CASES THAT HAVE PROVIDED SIGNED AUTHORIZATION
FOR RELEASE OF MEDICIAL RECORDS
1. Hello, may I please speak to someone in medical records?
Hello, my name is [Your Name] and I am calling on behalf of the Sister Study. The Sister Study is a
cohort study of 50,000 women who have a sister with breast cancer, conducted by the National Institute
of Environmental Health Sciences (NIEHS). If a participant develops breast cancer, we follow up with
her doctors to collect additional information. We are calling about one of your patients, [name], who is a
participant in The Sister Study. She has authorized us to collect detailed medical information. We want
to send you a packet that includes the signed authorization forms and a Medical Report Form.
[IF NOT THE CORRECT MEDICAL CARE FACILITY – END CALL]
[RECORD COMMENTS]
 _________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
2. Who should receive the packet?

 _________________________________________________

3. Can you please verify the address?
 _________________________________________________
[MAKE CORRECTIONS, IF NEEDED] _________________________________________________
_________________________________________________
4. [DO NOT ASK THIS QUESTION]
[DID PROVIDER MENTION THAT THERE WILL BE A COST INVOLVED WITH THIS SERVICE?]
1 YES 
GO TO 5.
2 NO

GO TO 7.

5. We are able to pay a small fee for your help.
[DOCUMENT COST IF VOLUNTEERED]

 $___________

6. Do we need to pre-pay this fee?
1 YES [DOCUMENT PAYMENT DETAILS]
 ____________________________________
______________________________________________________________________________
2NO
7. Thank you, we will mail the forms and information about the Sister Study in the next few days. Goodbye. [END]

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

National Institutes of Health
National Institute of
Environmental Health Sciences
Website: www.niehs.nih.gov

Provider Name
Address 1
Address 2
City, State Zip
RE:

DATE

Patient Name:

Date of Birth:

Last four digits of SSN: XXX-XX-< SSN 4-digits>

Dear :
We recently spoke to one of your staff about obtaining the medical record for the above-named patient, who is a
participant in The Sister Study. The Sister Study is a prospective study of 50,000 women whose sister had breast
cancer, conducted by the National Institute of Environmental Health Sciences (NIEHS), one of the National
Institutes of Health (NIH). The purpose of the study is to identify environmental and genetic factors that contribute
to breast cancer risk. The women in the study have provided us with detailed information on life and health
history in questionnaires completed at baseline, and every two years since the study began in 2004. They also
provided blood, urine, and home dust samples at baseline. For more information, please see the attached study
summary.
Your patient, , has told us that she was diagnosed with breast cancer in . She has
authorized us to collect information on her breast cancer diagnosis and treatment. We have enclosed a copy of
the patient’s signed Authorization for Release of Medical Information for your records. This form addresses
issues pertinent to the Federal Health Insurance Portability and Accountability Act (HIPAA).
We are requesting copies of pertinent pathology reports and test results, as well as sections of the medical record
covering breast cancer diagnosis and treatment. If possible, please also complete the medical report form, which
asks for details that you are in the best position to provide. IF NUMBER OF DIAGNOSES > 1: We have included
forms because the patient reported separate diagnoses to us. ALL: Please send the requested records
and completed medical report IF NUMBER OF DIAGNOSES > 1: forms ELSE: form ALL: within the next two
weeks using the enclosed envelope: The Sister Study, 1009 Slater Road, Suite 120, Durham, NC 27703.
Thank you in advance for your assistance to the Sister Study. While your participation is voluntary, it is very
important to the study to verify what the participant has told us about her diagnosis, and to collect detailed
information about her breast cancer diagnosis, tumor characteristics and treatment.
Please direct questions about this project to Heather Carroll, Sister Study Laboratory Supervisor, at (919) 2874574 or (800) 948-7552, ext. 4574. Thank you in advance for your assistance.
Sincerely,

Dale P. Sandler, Ph.D.
Chief, Epidemiology Branch
Principal Investigator of the Sister Study
Encl. IF NUMBER OF DIAGNOSES > 1: 2+N, ELSE: 3

The NIEHS Sister Study is prospectively examining
environmental and familial risk factors for breast cancer
and other diseases in a high-risk cohort of 50,000 sisters of
women who have had breast cancer. Such sisters have
about twice the risk of developing breast cancer as other
women. The frequency of any relevant genes and shared
risk factors will also be higher, increasing the statistical
power of the study. Sisters are expected to be highly
motivated to participate in a long-term study. Studying
sisters enhances our ability to assess the interplay of genes
and environment in breast cancer risk and to identify
potentially preventable risk factors. The prospective
design allows us to assess exposures before the onset of
disease thereby avoiding biases common to retrospective
studies and creates a framework for testing new
hypotheses.
Breast cancer-free sisters aged 35-74 years were recruited in
the US and Puerto Rico through health professionals,
breast cancer advocates, the Internet, recruitment
volunteers, and a national media campaign. Study
materials are available in English or Spanish.
Recruitment strategies were designed to maximize
inclusion of minorities and high-risk women. Data on
potential risk factors and current health status were
collected in telephone interviews and self-completed
forms. Blood, urine, and environmental samples were
collected and banked for future use in nested studies of
women who develop breast cancer or other diseases and
a sample of those who don’t. Stored samples include
whole blood, cryopreserved lymphocytes (15% random
sample), plasma, serum, urine, toenail clippings, and
household dust collected with alcohol wipes.
The cohort will be followed prospectively for 10 or more
years. Contact information, vital status, and changes in
health and exposures are updated in brief annually, and in
greater detail every 2-3 years. Medical records, pathology
reports, and tumor tissue blocks and slides are sought for
those patients develop cancer. Medical records will
also be sought to facilitate the study of other diseases of
importance to women.

About 300 new cases of breast cancer are expected to
occur in the cohort each year, with 1,500 cases after 5
years of follow-up. At that time, analyses will begin to
assess the independent and combined effects of
environmental exposures and genetic polymorphisms
that affect estrogen metabolism, DNA repair, and
response to specific environmental exposures. Future
analyses will focus on known and potential risk factors
(e.g. smoking, occupational exposures, alcohol, diet,
obesity) and include measurement of phthalates,
phytoestrogens, and metals in blood and urine, insulin,
growth factors, vitamins and nutrients, and genes.
Ancillary studies will explore risk for other diseases (e.g.
heart disease, osteoporosis, other hormonal cancers, and
autoimmune diseases) and explore genetic and
environmental effects on breast cancer prognosis by
continuing to follow women in the cohort who develop
breast cancer. A related effort, the Two Sister Study is
enrolling affected sisters diagnosed before age 50 and
within 4 years of the unaffected sister’s enrollment in the
Sister Study. Parents of these sister pairs are invited to
contribute saliva samples for DNA analysis.
The Sister Study opened nationally
in October 2004. More than
50,000 women have completed
all baseline activities.

Dale P. Sandler, Ph.D.
Principal Investigator

For more information, contact the Sister
Study Helpdesk, toll-free, at:
1-877-4SISTER (1-877-474-7837)
or by sending an email to:
info@sisterstudy.org.

WWW.SISTERSTUDY.ORG

July 31, 2009

Form: 31

Vers: 01

V. Date 05/06/2009

OMB: 0925-0522

Sister Study
Breast Cancer
Medical Report Form
Date of Birth:

Patient Name:

mm/dd/yyyy

2 0

Date this form completed:

mm/dd/yyyy

Doctor(s) and Address: (please print)
Doctor’s Name:

Phone: (

)

Doctor’s Name:

Phone: (

)

Affiliation:
Address:
City/Town:

Zip:

State:

Who Completed This Form? (please print)
Phone: (

Name:

)

INSTRUCTIONS: Please provide a copy of the breast cancer medical reports listed below and check the corresponding box. Also, please fill in as much of the attached form as possible. Please return the medical reports and this form
within the next 30 days using the enclosed addressed envelope. Thank you!
Have you enclosed a copy of the following medical reports?
Yes

No

(1) Pathology report from the breast biopsy;
Please provide or
correct pathologist
information below.

(2) Pathology report from the lumpectomy/mastectomy;
(3) Pathology report from the lymph node dissection;
(4) Estrogen and progesterone receptor assay report;
(5) Narrative discharge summary for the relevant admission(s);
(6) HER2NEU test results;
(7) Treatment Plan and/or summary;
(8) Other relevant records.

Name of Pathologist(s)/Lab:

Phone: (

)

Name of Pathologist(s)/Lab:

Phone: (

)

Address:
City/Town:
For Office Use Only:

State:
Date of Receipt ______ /______ /___________
1 of 12

Zip:
SIS ID #: _______________________

1. Date of Breast Cancer Diagnosis:

_____/_____/__________
mm/dd/yyyy

2. Total number of tumors: __________

Instructions: Please complete one column of the Tumor Characteristics grid for each individual
tumor per breast cancer diagnosis. If there was one tumor - complete column one only, two tumors
- complete two columns only, and so forth.
Tumor Characteristic

Tumor 1

Tumor 2

Tumor 3

Tumor 4

Tumor 5

Tumor 6

3.

Pathology Accession Number(s)

4.

Type

Invasive: _______%
In situ: _______%
Not documented

Invasive: _______%
In situ: _______%
Not documented

Invasive: _______%
In situ: _______%
Not documented

Invasive: _______%
In situ: _______%
Not documented

Invasive: _______%
In situ: _______%
Not documented

Invasive: _______%
In situ: _______%
Not documented

5.

Location

Ductal
Lobular
Mixed—ductal dominant
Mixed—lobular dominant
No primary location
evident
Not documented

Ductal
Lobular
Mixed—ductal dominant
Mixed—lobular dominant
No primary location
evident
Not documented

Ductal
Lobular
Mixed—ductal dominant
Mixed—lobular dominant
No primary location
evident
Not documented

Ductal
Lobular
Mixed—ductal dominant
Mixed—lobular dominant
No primary location
evident
Not documented

Ductal
Lobular
Mixed—ductal dominant
Mixed—lobular dominant
No primary location
evident
Not documented

Ductal
Lobular
Mixed—ductal dominant
Mixed—lobular dominant
No primary location
evident
Not documented

6.

Laterality

Right
Left
Not documented

Right
Left
Not documented

Right
Left
Not documented

Right
Left
Not documented

Right
Left
Not documented

Right
Left
Not documented

7.

Quadrant Location

Upper outer quadrant
Lower outer quadrant
Upper inner quadrant
Lower inner quadrant
Central
Nipple
Other, specify:
__________________
Not documented

Upper outer quadrant
Lower outer quadrant
Upper inner quadrant
Lower inner quadrant
Central
Nipple
Other, specify:
__________________
Not documented

Upper outer quadrant
Lower outer quadrant
Upper inner quadrant
Lower inner quadrant
Central
Nipple
Other, specify:
__________________
Not documented

Upper outer quadrant
Lower outer quadrant
Upper inner quadrant
Lower inner quadrant
Central
Nipple
Other, specify:
__________________
Not documented

Upper outer quadrant
Lower outer quadrant
Upper inner quadrant
Lower inner quadrant
Central
Nipple
Other, specify:
__________________
Not documented

Upper outer quadrant
Lower outer quadrant
Upper inner quadrant
Lower inner quadrant
Central
Nipple
Other, specify:
__________________
Not documented

8.

Evidence of LymphaticVascular Invasion (LVI)

Yes
No
Uncertain
Not documented

Yes
No
Uncertain
Not documented

Yes
No
Uncertain
Not documented

Yes
No
Uncertain
Not documented

Yes
No
Uncertain
Not documented

Yes
No
Uncertain
Not documented

9.

Tumor Size (single longest
dimension in cm)

10.

Method of Determination of
Tumor Size

____ ____ . ____ cm
Pathology
Mammography
Clinically
Not documented

2 of 12

____ ____ . ____ cm
Pathology
Mammography
Clinically
Not documented

____ ____ . ____ cm
Pathology
Mammography
Clinically
Not documented

____ ____ . ____ cm
Pathology
Mammography
Clinically
Not documented

____ ____ . ____ cm
Pathology
Mammography
Clinically
Not documented

____ ____ . ____ cm
Pathology
Mammography
Clinically
Not documented

3 of 12

Tumor Characteristic

Tumor 1

Tumor 2

Tumor 3

Tumor 4

Tumor 5

Tumor 6

11.

Tumor Histology Ductal

Invasive Ductal NOS
Invasive Ductal with
Lobular Tendencies
Mucinous
Medullary
Papillary
Tubular
Inflammatory
Comedo
Cribiform
Solid
Other, specify:
__________________
Not documented

Invasive Ductal NOS
Invasive Ductal with
Lobular Tendencies
Mucinous
Medullary
Papillary
Tubular
Inflammatory
Comedo
Cribiform
Solid
Other, specify:
__________________
Not documented

Invasive Ductal NOS
Invasive Ductal with
Lobular Tendencies
Mucinous
Medullary
Papillary
Tubular
Inflammatory
Comedo
Cribiform
Solid
Other, specify:
__________________
Not documented

Invasive Ductal NOS
Invasive Ductal with
Lobular Tendencies
Mucinous
Medullary
Papillary
Tubular
Inflammatory
Comedo
Cribiform
Solid
Other, specify:
__________________
Not documented

Invasive Ductal NOS
Invasive Ductal with
Lobular Tendencies
Mucinous
Medullary
Papillary
Tubular
Inflammatory
Comedo
Cribiform
Solid
Other, specify:
__________________
Not documented

Invasive Ductal NOS
Invasive Ductal with
Lobular Tendencies
Mucinous
Medullary
Papillary
Tubular
Inflammatory
Comedo
Cribiform
Solid
Other, specify:
__________________
Not documented

12.

Tumor Histology -Lobular

Invasive Lobular NOS
Invasive Lobular Classic
Invasive Lobular
Pleomorphic
Invasive Lobular with
Ductal Tendencies
Other, specify:
__________________
Not documented

Invasive Lobular NOS
Invasive Lobular Classic
Invasive Lobular
Pleomorphic
Invasive Lobular with
Ductal Tendencies
Other, specify:
__________________
Not documented

Invasive Lobular NOS
Invasive Lobular Classic
Invasive Lobular
Pleomorphic
Invasive Lobular with
Ductal Tendencies
Other, specify:
__________________
Not documented

Invasive Lobular NOS
Invasive Lobular Classic
Invasive Lobular
Pleomorphic
Invasive Lobular with
Ductal Tendencies
Other, specify:
__________________
Not documented

Invasive Lobular NOS
Invasive Lobular Classic
Invasive Lobular
Pleomorphic
Invasive Lobular with
Ductal Tendencies
Other, specify:
__________________
Not documented

Invasive Lobular NOS
Invasive Lobular Classic
Invasive Lobular
Pleomorphic
Invasive Lobular with
Ductal Tendencies
Other, specify:
__________________
Not documented

13.

Grade
1 = predominately welldifferentiated
2 = moderately differentiated/
balanced pattern
3 = poorly differentiated
ND = not documented

Overall grade ________

Overall grade ________

Overall grade ________

Overall grade ________

Overall grade ________

Overall grade ________

Nuclear grade ________

Nuclear grade ________

Nuclear grade ________

Nuclear grade ________

Nuclear grade ________

Nuclear grade ________

Tubular grade ________

Tubular grade ________

Tubular grade ________

Tubular grade ________

Tubular grade ________

Tubular grade ________

Mitotic grade

Mitotic grade

Mitotic grade

Mitotic grade

Mitotic grade

Mitotic grade

________

________

________

________

________

________

14.

Estrogen Receptor Assay (ERA)
Type

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

15.

Estrogen Receptor Assay (ERA)
Results

Positive
Negative
Borderline/marginal
Test not done
Not documented

Positive
Negative
Borderline/marginal
Test not done
Not documented

Positive
Negative
Borderline/marginal
Test not done
Not documented

Positive
Negative
Borderline/marginal
Test not done
Not documented

Positive
Negative
Borderline/marginal
Test not done
Not documented

Positive
Negative
Borderline/marginal
Test not done
Not documented

16.

ERA Value

17.

Progesterone Receptor Assay
(PRA) Type

ERA Value: ____________

ERA Value: ____________

ERA Value: ____________

ERA Value: ____________

ERA Value: ____________

ERA Value: ____________

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

Biochemical
Immunohistochemical
(ERICA)
Immunofluorescent
Not performed
Not documented

4 of 12

5 of 12

Tumor Characteristic
18.

Progesterone Receptor Assay
(PRA) Results

19.

PRA Value

20.

Tumor 1

Tumor 2

Positive
Negative
Borderline/marginal
Test not done
Not documented

Positive
Negative
Borderline/marginal
Test not done
Not documented

Tumor 3

Positive
Negative
Borderline/marginal
Test not done
Not documented

Tumor 4

Positive
Negative
Borderline/marginal
Test not done
Not documented

Tumor 5

Positive
Negative
Borderline/marginal
Test not done
Not documented

Tumor 6

Positive
Negative
Borderline/marginal
Test not done
Not documented

PRA Value: ____________

PRA Value: ____________

PRA Value: ____________

PRA Value: ____________

PRA Value: ____________

PRA Value: ____________

HER-2/NEU Assay Type

Immunohistochemistry
(IHC)
FISH, gene amplification
Both IHC and FISH
Not performed
Not documented

Immunohistochemistry
(IHC)
FISH, gene amplification
Both IHC and FISH
Not performed
Not documented

Immunohistochemistry
(IHC)
FISH, gene amplification
Both IHC and FISH
Not performed
Not documented

Immunohistochemistry
(IHC)
FISH, gene amplification
Both IHC and FISH
Not performed
Not documented

Immunohistochemistry
(IHC)
FISH, gene amplification
Both IHC and FISH
Not performed
Not documented

Immunohistochemistry
(IHC)
FISH, gene amplification
Both IHC and FISH
Not performed
Not documented

21.

Results of HER-2/NEU

Overexpressed
Not overexpressed
Test not done
Not documented

Overexpressed
Not overexpressed
Test not done
Not documented

Overexpressed
Not overexpressed
Test not done
Not documented

Overexpressed
Not overexpressed
Test not done
Not documented

Overexpressed
Not overexpressed
Test not done
Not documented

Overexpressed
Not overexpressed
Test not done
Not documented

22.

HER-2/NEU Value (IHC only)

0
+1
+2
+3
Test not done
Not documented

0
+1
+2
+3
Test not done
Not documented

0
+1
+2
+3
Test not done
Not documented

0
+1
+2
+3
Test not done
Not documented

0
+1
+2
+3
Test not done
Not documented

0
+1
+2
+3
Test not done
Not documented

23.

DNA Ploidy

Diploid/Euploid/Normal
(DNA Index 1.0)
Aneuploid/Abnormal
(DNA Index>1.0)
Test not done
Not documented

Diploid/Euploid/Normal
(DNA Index 1.0)
Aneuploid/Abnormal
(DNA Index>1.0)
Test not done
Not documented

Diploid/Euploid/Normal
(DNA Index 1.0)
Aneuploid/Abnormal
(DNA Index>1.0)
Test not done
Not documented

Diploid/Euploid/Normal
(DNA Index 1.0)
Aneuploid/Abnormal
(DNA Index>1.0)
Test not done
Not documented

Diploid/Euploid/Normal
(DNA Index 1.0)
Aneuploid/Abnormal
(DNA Index>1.0)
Test not done
Not documented

Diploid/Euploid/Normal
(DNA Index 1.0)
Aneuploid/Abnormal
(DNA Index>1.0)
Test not done
Not documented

24.

S-Phase

Low (or < reference)
Intermediate
High (or > reference)
Equivocal
Specify percentage:
_______%
Test not done
Not documented

Low (or < reference)
Intermediate
High (or > reference)
Equivocal
Specify percentage:
_______%
Test not done
Not documented

Low (or < reference)
Intermediate
High (or > reference)
Equivocal
Specify percentage:
_______%
Test not done
Not documented

Low (or < reference)
Intermediate
High (or > reference)
Equivocal
Specify percentage:
_______%
Test not done
Not documented

Low (or < reference)
Intermediate
High (or > reference)
Equivocal
Specify percentage:
_______%
Test not done
Not documented

Low (or < reference)
Intermediate
High (or > reference)
Equivocal
Specify percentage:
_______%
Test not done
Not documented

6 of 12

7 of 12

Surgical Treatment

Chemotherapy Treatment
Left Breast

25. Date of post-diagnosis
surgery

Right Breast

_____/_____/__________
mm/dd/yyyy

_____/_____/__________
mm/dd/yyyy

29. Neo-adjuvant (pre-surgery)
chemotherapy for breast cancer:
30. If yes,
Chemotherapy Regimen
(see list below)

26. Type of surgery

Lumpectomy
Other Breast Conserving
Therapy (BCT)
Mastectomy
No post-diagnosis surgery
performed
Not documented

Lumpectomy
Other Breast Conserving
Therapy (BCT)
Mastectomy
No post-diagnosis surgery
performed
Not documented

Yes
No
Not documented

Example:

ATC

# Cycles

Start date
mm/dd/yyyy

End date
mm/dd/yyyy
(if known)

2

02/01/2006

02/15/2006

31. Adjuvant chemotherapy
for breast cancer:

Mark if
therapy
on-going

Prescribed
dosing interval

q 2 weeks

Yes
No
Not documented

Lymph Node Involvement and Metastatic Results
32. If yes,
27. Lymph Node Involvement (Sentinel lymph node biopsy and final surgery combined)
Chemotherapy Regimen
(see list below)

Number sampled: _______________
Number malignant: ______________

28. Results of Metastatic
Work Up:

Example:

Completely negative
Incomplete or equivocal
Metastatic at diagnosis

CMF

# Cycles

Start date
mm/dd/yyyy

4

03/01/2006

End date
mm/dd/yyyy
(if known)

Mark if
therapy
on-going

Prescribed
dosing interval

q 2 weeks

Work up not performed
Not documented

LIST OF CHEMOTHERAPY REGIMENS FOR QUESTIONS 30 & 32:
AC—Adriamycin/Cytoxan
AT—Adriamycin/Taxol
ATC—Adriamycin/Taxol or Taxotere/Cytoxan
T—Taxol
CMF—Cytoxan/Methotrexate/Fluorouracil
CAF/FAC—Cytoxan/Adriamycin/Fluorouracil

8 of 12

9 of 12

EC - Epirubicin/Cytoxan
Td—Taxotere
FEC—Fluorouracil/Epirubicin/Cytoxan
T+H—Taxol plus Herceptin
Abraxane
Other—please specify

Biological Treatment

Radiation Treatment

33. Herceptin treatment for breast
cancer?

37. Radiation therapy:

Yes
No
Not documented

38. If yes,

34. If yes,
Start date
mm/dd/yyyy

Drug Name

End date
mm/dd/yyyy
(if known)

Mark if
therapy
on-going

Target Site
of Radiation
Treatment
Whole
Breast

Tumor Bed

Chest Wall

Hormonal Treatment
35. Hormonal treatments such as
tamoxifen, raloxifene, or
aromatase inhibitors [Arimidex
(Anastrozole), Femara
(Letrozole), Aromasin
(Exemestane)]?

Supraclavicular (SCV)

Yes
No
Not documented

Axilla
Intramammary nodes
(IMN)

Yes
No
Not documented

Left Breast

Right Breast
End date

Start date

mm/dd/
yyyy
(if known)

mm/dd/
yyyy

Mark if
therapy Cumulative
onDose (cGy)
going

Start date
mm/dd/
yyyy

End date
mm/dd/
yyyy
(if known)

_____/_____/ _____/_____/

_____/_____/ _____/_____/

___________

___________

___________

___________

_____/_____/ _____/_____/

_____/_____/ _____/_____/

___________

___________

___________

___________

_____/_____/ _____/_____/

_____/_____/ _____/_____/

___________

___________

___________

___________

_____/_____/ _____/_____/

_____/_____/ _____/_____/

___________

___________

___________

___________

_____/_____/ _____/_____/

_____/_____/ _____/_____/

___________

___________

___________

___________

_____/_____/ _____/_____/

_____/_____/ _____/_____/

___________

___________

___________

Mark if
therapy Cumulative
onDose (cGy)
going

___________

36. If yes,
(If dose changed, enter on a separate line)
Drug Name

Start date
mm/dd/yyyy

Clinical Trial Enrollment
End date
mm/dd/yyyy
(if known)

Dosage

Mark if
therapy
on-going

39. Enrolled in a clinical
trial for breast cancer
treatment/management:

Yes
No
Not documented

40. If yes,
Name or ID number of trial: _________________________________________________________________
Treatment(s) or procedure(s) tested: __________________________________________________________
__________________________________________________________________________________________
Treatment(s) or procedure(s) patient received as part of the trial (if known): _______________________
__________________________________________________________________________________________
Sponsor of trial (e.g. NIH, CALGB): ___________________________________________________________
___
41. Did patient complete the trial?:

10 of 12

Completed
Ongoing
11 of 12

Did not complete,
dropped out
Not documented

Genetic Testing
42. BRCA1 Genetic testing:

Positive
Specify Variant: _______________
Negative

Equivocal
Specify Variant: _______________
Test not done
Not documented

43. BRCA2 Genetic testing:

Positive
Specify Variant: _______________
Negative

Equivocal
Specify Variant: _______________
Test not done
Not documented

44. Other Genetic testing:
Type: ____________________________
Result: ___________________________

Molecular Profiling
45. Molecular Profiling and
Proliferation assay:

Yes
No
Not documented

46. If yes,
Assay Type
(e.g. MammaPrint, OncotypeDx, MIB-1, E-cadherin)

12 of 12

Score

Sister Study – Breast Cancer Follow-up, Provider Reminder Call Telephone Script
PROVIDER REMINDER CALL TELEPHONE SCRIPT –
SECOND CALL PLACED TO PROVIDERS OF BC CASES THAT HAVE NOT PROVIDED THE
REQUESTED RECORDS AND REPORTS WITHIN 3-6 WEEKS.
1. Hello, may I please speak to [NAME GIVEN DURING PROVIDER CALL] in medical records?
Hello, my name is [Your Name] and I am calling on behalf of the Sister Study. Several weeks ago we
mailed a letter requesting medical records for [name], a participant in our study. Did you receive the
letter and corresponding forms?

1
2

YES
NO




GO TO 2.
GO TO 5.

2. Do you have any questions?
1 YES 
[RECORD QUESTIONS AND COMMENTS]
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
2 NO
3. Will you be able to send us the requested materials?
1 YES 
Go to 4.
2 NO

[RECORD REASON] ______________________________________________
_________________________________________________________________
_________________________________________________________________
Thank you. Good-bye. [END]
4. If possible, we would like to receive the materials in the next two weeks. When do you estimate that you
will be able to send us the materials?
[RECORD TIMEFRAME] ______________________________________________
Thank you very much for your help. Good-bye. [END]
5. We will resend the packet to you.
Can you please verify the address?
 _________________________________________________
[MAKE CORRECTIONS, IF NEEDED] _________________________________________________
_________________________________________________
Thank you, we will re-mail the forms and information about the Sister Study in the next few days. Goodbye. [END]

Sister Study - Breast Cancer Follow-up, Pathologist Letter 1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

National Institutes of Health
National Institute of
Environmental Health Sciences
Website: www.niehs.nih.gov

DEPARTMENT OF PATHOLOGY
Provider Name
Address 1
Address 2
City, State Zip
RE:

Patient Name :
Date of Birth:
Last four digits of SSN
Accession number(s):

DATE

XXX-XX-

To: PATHOLOGY DEPARTMENT
The above named patient is a participant in a research study and has given us permission to retrieve tissue blocks and
slides pertaining to her breast cancer diagnosis in . The Sister Study, conducted by the National
Institutes of Health, is a prospective study of 50,000 women whose sister had breast cancer. The study is evaluating the
environmental and genetic factors that may contribute to breast cancer risk and exploring factors that may influence
long-term health following treatment. Participants have provided detailed information on their life and health history in
questionnaires completed at baseline and annually since enrollment. They also provided blood, urine, and
environmental samples. The molecular marker data from tissue blocks and slides will be especially valuable to this
research.
Enclosed is a copy of the patient's signed release form. We would be grateful if you would send:
1) For each breast tumor, two blocks containing representative samples of tumor tissue;
2) Two blocks containing normal breast tissue, if available;
3) Original diagnostic H&E slides (at least one slide for each block sent), if possible; and
4) The completed Pathology Checklist (enclosed).
We encourage you to retain some of the tumor tissue for possible future medical use, unless it would otherwise not be
kept. Unused portions of blocks we receive will be archived in our biorepository for at least 10 years, but we will gladly
return remaining tissue upon written request from the patient. Please send the requested specimens and checklist to:
The Sister Study
1007 Slater Rd, Ste 100
Durham, NC 27703
Attention: Cynthia Kleeberger
Please direct questions about the submission of blocks and slides to Cynthia Kleeberger, Laboratory Director of the
Sister Study (919-287-4577, kleeber2@niehs.nih.gov). Questions about the Sister Study can be directed to Dr. Dale
Sandler, Principal Investigator (919-541-4668, sandler@niehs.nih.gov). Thank you very much for your assistance.
Sincerely,

Dale P. Sandler PhD
Chief, Epidemiology Branch
Principal Investigator of the Sister Study

Form: 44 Version: 01

OMB: 0925-0522

v. Date 12/11/2008

Sister Study Pathology Checklist

Patient Name: ____________________________ Date of Birth:

/
(month)

Date this form completed:

/
(month)

(day)

(year)

Date of tumor biopsy/removal:

/
(day)

/

/

(year)
(month)

/
(day)

(year)

Facility Name and Address: (please print)
Facility Name: ___________________________________________________________________________
Telephone: (

) ___________________________

Address: ________________________________________________________________________________
Who completed this form? (please print)
Name: _________________________________________Telephone: (

) _________________________

INSTRUCTIONS: Please check all of the following that apply. If more than one tumor was diagnosed,
complete a separate checklist for each tumor.
(Please note: H&E slides should correspond to the tissue blocks. If original H&E slides are not
available, please DO NOT make new H&E slides.)
Normal Tissue Blocks and Original H&E Slides
□ I am sending _____ block(s) and _____ slide(s) containing normal breast tissue.
Block 1 Accession #_____________________Corresponding Slide 1 Accession # ______________________
Block 2 Accession #_____________________Corresponding Slide 2 Accession # ______________________
Tumor Tissue Blocks and Original H&E Slides
□ I am sending _____ block(s) and _____ slide(s) containing breast carcinoma tissue.
Block 1 Accession #_____________________Corresponding Slide 1 Accession #______________________
Block 2 Accession #_____________________Corresponding Slide 2 Accession #______________________
□

I have no original H&E slides.

Other information
□ Our hospital has no record of this patient.
□

We no longer have this material. You need to contact:

Name:
Hospital/Lab:
Street:
City/State/Zip:
Phone:

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

Comments:

________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

□

Thank you for your response. Please return this form and samples to:
The Sister Study
1007 Slater Road, Ste. 100
Durham, NC 27703
Attention: Cindy Kleeberger, Laboratory Director

Sister Study - Breast Cancer Follow-up, Pathologist Letter 2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

National Institutes of Health
National Institute of
Environmental Health Sciences
Website: www.niehs.nih.gov

DEPARTMENT OF PATHOLOGY
Provider Name
Address 1
Address 2
City, State Zip
RE:

Patient Name :
Date of Birth:

DATE

To: PATHOLOGY DEPARTMENT
Thank you for sending us the tissue blocks and slides from , who is a participant in the Sister Study.
The Sister Study aims to examine the environmental, lifestyle, and genetic factors that may make some
women more likely than others to develop breast cancer and also to study factors that may influence the
long-term health of women after treatment for breast cancer. With access to the pathology specimens that
you and many other pathology departments have provided, we will also be able to examine the importance
of specific molecular markers in breast cancer risk.
As stated in our initial letter, blocks we receive for our later analyses will be archived at the NIEHS
biorepository for at least 10 years, but we will gladly return remaining tissue to you upon written request from
the patient.
If you have any questions about the submission of blocks and slides please contact Cynthia Kleeberger,
Laboratory Director of the Sister Study, phone (919) 287-4577, email kleeber2@niehs.nih.gov. We will be
happy to return what we have.
Your cooperation and support of the Sister Study is greatly appreciated.
Sincerely,

Dale P. Sandler PhD
Chief, Epidemiology Branch
Principal Investigator of the Sister Study