Attachment A Precision Medicine Survey

Attach A Precision Medicine Survey.pdf

The National Physician Survey of Precision Medicine in Cancer Treatment (NCI)

Attachment A Precision Medicine Survey

OMB: 0925-0739

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Please Note:
This survey is about genomic testing for cancer treatment, also known as precision
or personalized medicine. It is intended for oncologists who have treated or
evaluated patients with cancer, including hematologic malignancies and solid
tumors. If you have NOT treated or evaluated any patients with any type of cancer
in the past 12 months, please check the box below and return the blank survey in
the envelope provided.

I have not treated or evaluated cancer patients in the past 12 months.

INTRODUCTION
This survey is about genomic testing for cancer treatment, also known as precision or personalized
medicine. You are one of 3,000 oncologists in the United States randomly sampled to take part in this important
research. The survey should take about 20 minutes to complete.
The survey is sponsored by the National Cancer Institute, the National Human Genome Research
Institute, and the American Cancer Society to help better understand current and potential use of genomic
tests, including single gene tests and multi-marker tumor panels. The findings from the survey will also be used
to identify future research needs and to help inform the development of educational materials for providers and
patients.
NCI is being assisted by RTI International in fielding this survey. The survey is voluntary, but it is important to
the success of the study that everyone chosen takes part.
The information you provide will be kept private, and your name or any other information that could identify you
will not be associated directly with the results.
If you would like further information about the survey please contact RTI International at 1-866-590-7469 or email: PrecisionMedicine@rti.org.
If you would like further information about how RTI International ensures that this NCI survey is carried out
ethically and protects respondent privacy, please contact RTI International’s Office of Human Research
Protection at http://www.rti.org/page.cfm/Human_Research_Protection.
We thank you in advance for your time and your valuable contribution to this research.
OMB No. 0925-xxxx
Expiration XX/XX/20XX
Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of study
participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not
participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The
information collected in this study will be kept private to the extent provided by law. Names and other identifiers will not
appear in any report of the study. Information provided will be combined for all study participants and reported as
summaries. You are being contacted by mail to complete this instrument so that we can understand how genomic testing
results are used to inform cancer treatment.
Public reporting burden for this collection of information is estimated to average 20 minutes per response, including the time
for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden
estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX). Do not return
the completed form to this address.

Survey instructions
• For each question, please fill in one box

or write in an answer as requested.

• If your answer is not adequately represented by available choices, please write in after
“Other (Please specify):

.”

SECTION A: YOUR PATIENT POPULATION
This questionnaire focuses on treatment and evaluation of patients with cancer, including hematologic
malignancies and solid tumors.

A1. On average, how many unique patients do you see for evaluation or treatment each month? Of those, how
many are cancer patients? Your best estimate is fine.
Total unique patients per month
Unique cancer patients per month

A2. On average, how many unique patients with the following cancers do you see for evaluation or treatment
each month?

(Please check one box in each row.)

1-10 patients
per month


None


11-25
patients
per month


26-50
patients
per month


51+ patients
per month


a. Breast cancer
b. Colorectal cancer
c. Glioma
d. Gynecological cancer
e. Hematological cancer
f. Kidney cancer
g. Lung cancer
h. Melanoma
i. Stomach (Gastric) cancer
j. Other Solid Tumor

A3. By newly diagnosed, we mean patients who were diagnosed with cancer for the first time and have not yet
started treatment. On average, how many newly diagnosed cancer patients do you see for evaluation or
treatment each month? Your best estimate is fine.
Newly diagnosed cancer patients

A4. By metastatic, we mean cancer that has spread to other parts of the body. By recurrent, we mean cancer that
has come back after a period of time during which the cancer could not be detected. On average, how many
patients with metastatic or recurrent cancers do you see for evaluation or treatment each month? Your best
estimate is fine.
Metastatic or recurrent cancer patients

1

SECTION B: MULTI-MARKER TUMOR PANEL TESTING
Section B focuses on your use of and experience with multi-marker tumor panels such as FoundationOne or
Target Now. For this survey, a multi-marker tumor panel is defined as a test that allows multiple genes to be
assessed for mutations, alterations, or expression that may provide clinically actionable information.
We will ask about single gene tests (tests for individual genes or chromosomal mutations) in Section C.

B1. How of many of your cancer patients received the following multi-marker tumor panels within the past
12 months? Please include tests that were ordered by other physicians and tests performed by pathology.

(Please check one box in each row.)

Not familiar
with this
test


Familiar
with this
test, but not
used in the
past
12 months


1-10
patients in
the past
12 months


11-25
patients in
the past
12 months


26+
patients in
the past
12 months


a. BioSpeciFix (Precision Therapeutics)
b. DecisionDX (CastleDx)
c. FoundationOne (Foundation Medicine)
d. FoundationOne Heme (Foundation
Medicine)
e. Mammaprint (Agendia)
f. OncoPlex (Diagnostics)
g. Oncotype DX Breast (Genomic Health)
h. Oncotype DX Colon (Genomic Health)
i. Prosigna (NanoString Technologies)
j. Response DX (Response Genetics)
k. Solid Tumor Mutation Panel (ARUP)
l. Suraseq 7500 (AsuraGen)
m. Target Now (Caris Molecular
Intelligence)
n. Other (Please specify):
o. Other (Please specify):

The next section asks additional questions about multi-marker tumor panels. For these questions please exclude
Oncotype DX for breast.

B2. In the past 12 months, for what percentage of your patients receiving multi-marker tumor panels, excluding
Oncotype DX for breast, did you use the results to guide patient care decisions? Your best estimate is fine.
% [If 0, go to Question B12]

2

B3. In the past 12 months, how often did you use the results from multi-marker tumor panels, excluding
Oncotype DX for breast, to guide care decisions when treating the following types of patients?

(Please check one box in each row.)

Did not
see these
patients


Never


Rarely


Sometimes


Often


Always or
almost
always


a. Patients with an initial diagnosis of cancer
b. Patients with advanced refractory disease
c. Patients with rare cancers
d. Patients with cancers of unknown origins
e. Patients for whom there is an FDAapproved therapy associated with a
companion diagnostic
f. Patients on specific clinical trials that have
a companion molecular test

B4. In the past 12 months, have you used the results from multi-marker tumor panels, excluding Oncotype DX
for breast, for the following purposes?
Yes


(Please check one box in each row.)

No


a. To guide the use of FDA-approved drugs
b. To help decide whether to use FDA-approved drugs for an off-label use
c. To provide diagnostic information
d. To provide prognostic information
e. To determine patient eligibility for clinical trials
f. Other (Please specify):

B5. In the past 12 months, when you used the results of multi-marker tumor panels for your patients, excluding
Oncotype DX for breast, how often did you experience the following?

Never


(Please check one box in each row.)
a. The test results assisted in making a diagnosis
b. The test results helped to inform my treatment
recommendations
c. The test results provided important information on
prognosis
d. The test results were helpful to patients or their
families in understanding their disease and making
decisions
e. The test results were conclusive, but not actionable
f. The test results were inconclusive/indeterminate
g. The test results were difficult to interpret
h. The recommended drugs based on test results were
not covered by insurance
i. The test results confirmed eligibility for a clinical trial

3

Rarely


Sometimes


Often


Always
or almost
always


B6. In the past 12 months, when you ordered or requested multi-marker tumor panels for your patients,
excluding Oncotype DX for breast, how often did you experience the following?

(Please check one box in each row.)

Never


Rarely


Sometimes


Often


Always
or almost
always


Don’t
Know


a. At least some costs were covered
by insurance
b. Inadequate reimbursement was
paid to physician or hospital
c. Uncertainty as to whether the test
was indicated for patient’s clinical
situation
d. Long wait to receive tests results
that caused a delay in making
patient care decisions
e. Patient reluctance because of
concern that hereditary genetic
abnormalities might be found

B7. In the past 12 months, how important was each of the following factors in your decision to use multi-marker
tumor panels to make treatment decisions for your cancer patients?
Not at all
important


(Please check one box in each row.)

A little
important


Somewhat
important


Very
important


a. Availability of guidelines (e.g., ASCO, NCCN) for the test
b. Your familiarity with guidelines (e.g., ASCO, NCCN) for the test
c. Your formal education or training (e.g., residency/fellowship,
CME, lecture or symposia) on the test
d. Past experience with the test
e. FDA approval of the test for the patient population being tested
f. Information about the test from test suppliers or company
representatives

B8. In the past 12 months, how important was each of the following factors in your decision to use multi-marker
tumor panels to make treatment decisions for your cancer patients?

(Please check one box in each row.)

Not
applicable


a. Performance characteristic of the test (e.g.,
positive predictive value, sensitivity, specificity)
b. Prevalence of genetic alterations among
patients with a specific type of cancer
c. Ability of the test to predict clinical benefit of
specific treatments
d. Ability of the test to predict toxicity of specific
treatments
e. Ability of the test to provide prognostic
information
f. Ability of the test to provide diagnostic
information (e.g., for a cancer of unknown
primary)

4

Not at all
important


A little
important


Somewhat
important


Very
important


B9. In the past 12 months, how important was each of the following factors in your decision to use multi-marker
tumor panels to make treatment decisions for your cancer patients?
Not at all
important


(Please check one box in each row.)

A little
important


Somewhat
important


Very
important


a. Patient or family preferences
b. Test covered by patient's insurance
c. Treatment is covered by patient's insurance
d. Patient out-of-pocket expenses for testing
e. Patient out-of-pocket expenses for treatment

B10. In the past 12 months, how often, if at all, did you use the following practice guidelines or recommendations
for multi-marker tumor panels when making treatment decisions for cancer patients?

(Please check one box in each row.)

I am not
familiar
with these
guidelines


Never


Rarely


Sometimes


Often


Always
or almost
always


a. American Society of Clinical
Oncology (ASCO)
b. Blue Cross Blue Shield (BCBS) or
the BCBS Technical Evaluation
Center
c. Evaluation of Genomic
Applications in Practice and
Prevention (EGAPP)
d. National Comprehensive Cancer
Network (NCCN)
e. Other (Please specify on the line
below):

B11. In the past 12 months, what percentage of your cancer patients initiated a discussion with you about multimarker tumor panels? Please include when a family member or other caregiver asked on the patient's
behalf. Your best estimate is fine.

%

5

B12. The next question is about the times during the past 12 months when you decided NOT to order a multimarker tumor panel for a cancer patient. When this occurred, how often was it for the following reasons?

(Please check one box in each row.)

Never


Rarely


Sometimes


Often


Always
or almost
always


a. Multi-marker testing was not relevant for the
patient
b. Used tests for individual genes, rather than
multi-marker tumor panels
c. Not enough evidence of utility
d. Multi-marker panels were not available in my
practice
e. Test was not covered by patient’s insurance
f. Out-of-pocket costs for tests were too
expensive for the patient
g. Provider reimbursement for tests was
insufficient
h. Lack of personnel or resources to interpret test
results
i. Uncertainty regarding informed consent
procedures
j. Difficulty obtaining sufficient tissue for testing
k. Insufficient time to order tests or review results
l. Patient's or patient’s family preferences

B13. In the past 12 months, how often, if at all, were the following barriers to involving your cancer patients or
their families in the decision-making process for multi-marker tumor panels?

(Please check one box in each row.)

Never


a. Difficulty getting patient/family to understand
the purpose of the test
b. Difficulty getting patient/family to understand
treatment options
c. Lack of educational materials to share with
patient/family
d. Insufficient time to discuss testing or treatment
options with patient/family
e. Patient/family resistant to testing
f. Lack of patient/family interest in testing

6

Rarely


Sometimes


Often


Always
or almost
always


B14. In the past 12 months, did you rely on any of

B17. In the past 12 months, what percentage of
your cancer patients presented with results
from a commercially available multi-marker
tumor test that was not ordered through you
or your practice?

the following to learn about using a new multimarker tumor panel for cancer patients?
(Please check one box in each row.)

Yes

No





a. Informal networks (e.g.,
colleagues)

None

Go to Section C, page 8

<10%

b. National or international experts

11%-25%

c. Testing laboratories or
pathologists

26%-50%
51%-80%

d. Test manufacturers or drug
company representatives or
websites

>80%

e. FDA package inserts

B18. In the past 12 months, when patients
presented with commercially available multimarker tumor testing results that you did not
order, did you take any of the following
courses of action?

f. Scientific meetings or conferences
g. Peer-reviewed medical literature
h. Medical professional societies
such as ASCO or NCCN

(Please check one box in each row.)

i. Government (e.g., NIH) websites
or materials

a. Consulted with your local Tumor
Board

j. Foundation or cancer patient
advocacy websites or materials

b. Consulted with a pathologist

k. Evidence-based, synthesized
websites (e.g., UpToDate)

c. Considered patient preferences for
treatment

l. Other (Please specify):

d. Ordered additional single gene
tests
e. Ordered additional multi-marker
tumor tests

B15. In the past 12 months, did you refer any of
your cancer patients to another location or
provider for a multi-marker tumor panel?

f. Spoke with the manufacturer of the
test
g. Consulted literature regarding the
test

Yes

No

Go to Question B17

h. Referred to a cancer center

B16. In the past 12 months, did you refer any of

i. Referred to a colleague

your cancer patients to any of the following for
a multi-marker tumor panel?
(Please check one box in each row.)

Yes


j. Used results to guide patient care
decisions

No


k. Enrolled patient in a clinical trial

a. Comprehensive Cancer Center
b. Academic medical center
c. Oncologist outside your practice
d. Clinical trial
e. Other (Please specify):

7

Yes


No


SECTION C: GENOMIC TESTING
The previous questions asked about multi-maker tumor panels. This section asks about both multi-marker tumor
panel testing and single gene tests (tests for individual genes or chromosomal mutations).

C1. In the past 12 months, have you used results from genomic tests (either multi-marker tumor panels or single
gene tests) for any of the following individual genes or chromosomal mutations to make treatment decisions for
your cancer patients?
(Please check one box in each row.)

Yes


No


(Please check one box in each row.)

Stomach Cancer

Glioma

a. KIT mutation

o. 1p/19q deletion

b. HER2/neu amplification

p. IDH mutation

Colon Cancer

q. MGMT mutation
Melanoma

c. BRAF mutation
d. KRAS mutation

r.

BRAF mutation

Lung Cancer

e. Microsatellite instability (MSI)
Hematologic Malignancy
f.

s. EGFR amplification/mutation

BCL2-IGH translocation

t.

ERCC1 mutation

g. BCR-ABL translocation

u. EML4-ALK translocation

h. KIT mutation

v. KRAS mutation

i.

FLT3 mutation

j.

IGH rearrangement

w. ROS1 mutation
Breast Cancer

k. JAK2 mutation
l.

Yes


x. HER2/neu amplification
Other Genes or Mutations

MPL mutation

m. PML-RARA translocation

Please specify gene/mutation (and cancer type):

n. TRG rearrangement

If you have not used the results of ANY genomic tests (multi-marker tumor panels or single gene tests)
for your cancer patients in the past 12 months, please go to Question D1, page 10.

C2. In the past 12 months, when you or your staff discussed any form of genomic testing with your cancer
patients or their families, how often did you discuss the likely costs of the testing and related treatment?
Never
Rarely
Sometimes
Often
Always or almost always
Not discussed in past 12 months

8

No


C3. For each of the following tests, how confident are you in your ability to determine whether the test is
clinically appropriate for a patient?

(Please check one box in each row.)

Not at all
confident


A little
confident


Moderately
confident


Very
confident


Extremely
confident


a. Commercially available multi-marker tumor
panels (e.g., FoundationOne, Oncotype DX)
b. In-house multi-marker tumor panels
c. Whole genome sequencing
d. Tests for individual genes or chromosomal
mutations (e.g., KRAS for colorectal cancer)
e. Whole exome sequencing

C4. For each of the following tests, how confident are you in your ability to explain the testing purpose and
procedures to a patient?

(Please check one box in each row.)

Not at all
confident


A little
confident


Moderately
confident


Very
confident


Extremely
confident


a. Commercially available multi-marker tumor
panels (e.g., FoundationOne, Oncotype DX)
b. In-house multi-marker tumor panels
c. Whole genome sequencing
d. Tests for individual genes or chromosomal
mutations (e.g., KRAS for colorectal cancer)
e. Whole exome sequencing

C5. For each of the following tests, how confident are you in your ability to use the results of the test to guide
decisions about patient treatment and management?

(Please check one box in each row.)

Not at all
confident


a. Commercially available multi-marker tumor
panels (e.g., FoundationOne, Oncotype DX)
b. In-house multi-marker tumor panels
c. Whole genome sequencing
d. Tests for individual genes or chromosomal
mutations (e.g., KRAS for colorectal cancer)
e. Whole exome sequencing

9

A little
confident


Moderately
confident


Very
confident


Extremely
confident


SECTION D: BREAST CANCER
The next few questions are about breast cancer patients.

D1. In the past 12 months, have you seen any breast cancer patients for evaluation or treatment?
Yes
No

Go to Section E

D2. A female patient presents with ER+, HER2- breast cancer with a high recurrence score (≥ 26) from the
OncotypeDX Breast Cancer Assay. Which of the following factors would be important to you in deciding
whether to recommend chemotherapy for this patient?
Yes


(Please check one box in each row.)

No


a. Age ≥ 75
b. Presence of cardiomyopathy
c. Black or African American race
d. Patient’s inability to pay out-of-pocket expenses
e. Patient’s preferences not to receive therapy
f. Other (Please specify):

D3. A female patient presents with ER+, HER2- breast cancer with a low recurrence score (<18) on the
OncotypeDX Breast Cancer Assay. Which of the following factors would be important to you in deciding
whether to recommend chemotherapy for the patient?
Yes


(Please check one box in each row.)
a. Age ≤ 45
b. No comorbidities, otherwise healthy patient
c. Black or African American race
d. Patient ability to pay out-of-pocket cost
e. Patient’s amenability to chemotherapy
f. Other (Please specify):

SECTION E: LUNG CANCER
The next few questions are about lung cancer patients.

E1. In the past 12 months, have you seen any lung cancer patients for evaluation or treatment?
Yes
No

Go to Section F, page 11

10

No


E2. A 57-year-old man presents with increased dyspnea on exertion and is diagnosed with Stage IV non-small
cell lung cancer with adenocarcinoma histology. His relevant medical history includes 35 pack-years of
smoking; he quit 5 years ago. He has an excellent performance status (ECOG PS 1). For which of the
following mutations would you consider requesting or ordering a genomic test, and when would you order
the test?

(Please check one box in each row.)
Test
a. EGFR Mutation

All such
patients are
tested at time
of diagnosis
(reflex testing)


I would test
THIS patient
at time of
diagnosis


I would wait until
the time of
progression to
consider


I would not
order the
test for THIS
patient


b. ALK rearrangement
c. ROS1 rearrangement
d. KRAS Mutation
e. RRM1 Expression
f. ERCC1 Expression
g. BRAF Mutation
h. Next generation sequencing

SECTION F: COLORECTAL CANCER
The next few questions are about colon cancer patients.

F1. In the past 12 months, have you used multi-marker tumor testing to guide care decisions for colorectal cancer
patients?
Yes
No

Go to Section G, page 12

F2. For each of the following clinical scenarios, at what point in time, if at all, would you request a multi-marker tumor
test for your colorectal cancer patients? (Mark one box for each clinical scenario.)

(Please check one box in each row.)
Test
a. A newly diagnosed 74-year-old man with Stage
IV KRAS mutant colon cancer

All such
patients are
tested at time
of diagnosis
(reflex testing)


b. A 35-year-old woman with metastatic colon
cancer recently progressed on first line therapy
and found to have a BRAF mutation
c. A 65-year-old woman with Stage II disease
with high risk features of perforation
d. A 45-year-old woman with Lynch Syndrome
presenting with Stage III disease receiving
adjuvant therapy with FOLFOX

11

I would test
THIS patient
at time of
diagnosis


I would wait
until the time
of
progression
to consider


I would not
order the test
for THIS
patient?


SECTION G: ABOUT YOU AND YOUR PRACTICE
The next set of questions will help us to better understand
you and your primary medical practice. By primary
medical practice we mean the site where you see most of
your cancer patients.

G6. In 2014, what percentage of your patients were
Medicare, Medicaid, and self-pay/uninsured?
% Medicare
% Medicaid

G1. Is your primary practice a …

% Self-pay/uninsured

Solo practice
Single specialty group

G7. In which of the following practice settings do

Multi-specialty group

you see patients for treatment or evaluation?

Other (Please specify):

(Please check all that apply)
Academic medical center or medical
school

G2. Including yourself, how many full- and part-time
physicians are in your primary practice?

Medical center not affiliated with a
medical school

Number

Community hospital

G3. How would you characterize your primary practice?

Office-based

Urban

Integrated healthcare delivery system

Suburban

Other (Please specify):

Rural

G4. Does your primary practice provide care for patients
living in rural areas as part of an outreach or visiting
clinician arrangement?
Yes
No

G8. Is your primary practice affiliated with an
academic institution such as a medical school
or teaching hospital? Do not include where
your practice only has admissions privileges.
Yes
No

G5. Does your primary practice have the following
genomic testing services?

(Please check one box in each row.)

Yes


No


Don't
know


a. On-site pathology

Lastly, we have just a few more questions about you
and your background.

G9. What is your primary specialty? Please think
about the one specialty in which you spend
most of your time.

b. Contracts with outside testing
laboratories to perform tests
not available on-site

Medical oncology

c. On-site genetic counselors

Hematology

d. Internal policies or protocols
or use of genomic and biomarker
testing

Hematology/oncology
Pediatric hematology/oncology
Other (Please specify):

e. An EMR that alerts providers when
a genomic test is recommended
for a particular patient or before
ordering a particular drug

12

G10. For how many years have you been practicing in

G13. Have you received any formal training (e.g.,

your primary specialty? Please specify in whole
years, rounding up to the nearest year.

instruction during residency/fellowship, professional
lectures or seminars, symposiums, conferences,
CMEs) in use of genomic testing?

years

Yes
No

G11. Do you hold a faculty appointment or do you
have a teaching assignment at a medical school
or hospital?

G14. Which of these best describes your ethnicity?

Yes

(Choose one)

No

Hispanic or Latino
Not Hispanic or Non-Latino

G12. During a typical month, approximately what
percentage of your professional time do you
spend in the following activities?

G15. Which of these best describes your race?

% Providing patient care

(Choose one or more)
American Indian or Alaska Native

% Research

Asian
Black or African American

% Teaching

Native Hawaiian or Other Pacific Islander
White

% Administration

Thank you for taking the time to complete this questionnaire. Your contribution is
valuable to us. The information you have provided will be kept private and any
information that could identify you will not be associated directly with the results.
If you have any additional thoughts about any of the survey topics or the survey itself,
please share them here:

Please return this questionnaire in the enclosed postage-paid
return envelope or fax back to 1-XXX-XXX-XXXX.
If you have questions about this survey, please email us at
PrecisionMedicine@rti.org or call us toll-free at 1-866-590-7469.

13


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