Sub-Study Mini SSA NCORP Site Level Attributes

Mini SSA - NCORP Practice Level Survey 2.28.2020.docx

Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)

Sub-Study Mini SSA NCORP Site Level Attributes

OMB: 0925-0046

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Mini Supporting Statement A





NCI Community Oncology Research Program (NCORP)

Practice Survey of Site Level Attributes (NCI)



OMB# 0925-0046,

Expiration Date: 11/30/2022

A Generic Submission for Formative Research,

Pretesting, and Customer Satisfaction of

NCI’s Communication and Education Resources (NCI)



February 28, 2020







Contact Information

Brenda Adjei

Program Director

Division of Cancer Control and Population Sciences (DCCPS)

National Cancer Institute (NCI)

9609 Medical Center Drive, Room 3E516

Bethesda, MD 20892-9761(For UPS/FedEx, use: Rockville, MD 20850)

Phone: (240) 276-6185

Email: adjeiba@mail.nih.gov


List of Attachments



Attachment 1: NCORP Practice Site Level Attributes Survey







Mini Supporting Statement A



A.1 Circumstances Making the Collection of Information Necessary


Overview

The National Cancer Institute (NCI) conducts various types of research to identify and learn about target audiences. This research helps ensure that NCI communication and education resources are appropriate, useful, and effective. Consistent with this objective, the NCI Community Oncology Research Program’s (NCORP) Cancer Care Delivery Research (CCDR) program is seeking to collect information to: 1) inform the design and development of NCI resources and ensure that they are appropriate, effective, and reach the intended audiences; 2) monitor audience trends; and 3) inform efforts to assess the impact of resources and activities. The informa­tion obtained from this research will lead to programmatic improve­ments in materi­als and strategies.  By maximiz­ing the effective­ness of these strategies for reaching targeted audienc­es, the frequen­cy with which programs may need to be modified could be reduced.

Background

Cancer care delivery research (CCDR) is a major component of the NCI Community Oncology Research Program (NCORP) in 2014. NCORP is comprised of over 1,000 community oncology practices across 45 States and two territories charged with providing NCI-supported clinical trials access to a diverse patient population from varied care delivery settings. Expanding clinical research across this network allows access to a larger and more diverse patient population, reflects the complexity of cancer care delivery, can accelerate research translation into clinical practice, as well as increase the generalizability and relevance of study findings. NCORP CCDR leverages these network strengths and seeks to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that may influence care delivery. The CCDR program has seen tremendous growth over the past five years of funding and consists of 19 studies that identify modifiable factors and assess the effectiveness of interventions to improve care delivery, particularly at the clinician and organization level, across diverse healthcare settings.

Rationale for this Formative Research Request

Despite the impressive portfolio of NCORP CCDR studies, barriers to site participation in CCDR studies are a concern. Ineffective and inconsistent approaches/strategies to site recruitment can cause delays in activating CCDR studies, influence representativeness of participating sites, and potentially diminish scientific and clinical impact. Thus, attaining a better understanding of strategies that enhance study promotion as well as the selection, recruitment, and retention of eligible community sites/practices is a program need. The proposed formative research will address this gap by collecting practice-level characteristics for practices (affiliate/sub-affiliate) that participate in a CCDR trial. Evaluation of these practice-level characteristics/ attributes will facilitate the identification and adoption of best practices relatively early in NCORP initiative, while modifications are possible and feasible. The results of the formative research will be used to inform trial design, increase practice recruitment from diverse care delivery settings and representativeness within clinical trials, as well as improve an understanding of challenges/barriers to practice participation in CCDR studies. Furthermore, findings can inform tailored recruitment and communication strategies, guide programmatic improvements that maximize the effectiveness and impact of these strategies, and enhance the impact of NCORP CCDR.





A.2 Purpose and Use of the Information Collection

This survey is being administered to better understand the characteristics of NCORP oncology practices that are participating in cancer care delivery research trials. Results from this survey will be used to improve NCI’s outreach, communication, and training efforts and to inform study design considerations, increase practice recruitment and generalizability of clinical trials, and enhance an understanding of challenges/barriers to practice participation in CCDR studies.

A.3 Use of Information Technology to Reduce Burden

Online technology provides benefits that traditional paper surveys do not. NCORP practices (affiliates/sub-affiliates) will upload survey data directly to the Clinical Trials Supporting Unit (CTSU) web portal. Information is captured in real-time, eliminating the need to mail in the survey or provide further information, and participants are able to take the survey from anywhere. All responses will be submitted electronically.

A.4 Efforts to Identify Duplication

No other similar collection of information exists.



A.5 Impact on Small Businesses or Other Small Entities

This information collection will have no impact on small businesses or other small entities.



A.6 Consequences of Collecting the Information Less Frequently

The survey will be submitted by NCORP practices as a one-time data collection, in order to have a better sense of the characteristics of the current participants and improve/tailor recruitment efforts.



A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This survey will be implemented in a manner that fully complies with 5 C.F.R. 1320.5.



A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency

N/A



A.9 Explanation of Any Payment of Gift to Respondents

No payments or gifts will be given to respondents.



A.10 Assurance of Confidentiality Provided to Respondents

All information will be kept private to the extent allowable by law.



A.11 Justification for Sensitive Questions

No sensitive questions are being asked. The respondents for this survey are reporting aggregate practice-level data describing the proportion of populations served (by race and ethnicity) in the practice’s catchment area. No individual/person level data is being collected.



A.12 Estimates of Hour Burden Including Annualized Hourly Costs

Site coordinators will serve as respondents and will take approximately 10 minutes to complete the NCI Community Oncology Research Program Practice Survey of Site-Level Attributes. The total estimated annualized burden is 100 hours. (Table A.12-1) and the cost to the respondents is estimated to be $4,564.00 (Table A.12.2).

A.12-1 Estimated Annualized Burden Hours


Type of Respondent

Number of Respondents

Number of Responses per Respondent

Average Time Per Response

(in hours)

Total Annual Burden Hours

Individuals -

(NCORP Administrators)

600

1

10/60

100

Totals


600


100


A.12-2 Annualized Cost to the Respondents


Type of Respondents

Total Annual

Burden Hours

Hourly Wage Rate*

Respondent Cost

Individuals

100

$45.80

$4,580.00

Total


$4,580.00

*Source of the Mean Hourly Wage Rate is provided by the Bureau of Labor Statistics, Occupation title “Medical Scientists” 19-1040, https://www.bls.gov/oes/2018/May/oes_nat.htm#00-0000.

A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no capital costs, operating costs, or maintenance costs to report.



A.14 Annualized Cost to the Federal Government

The annualized cost to the Federal government is estimated to be $707.67 (Table A.14-1).



A.14-1 Annualized Cost to the Federal Government

Staff

Grade/Step

Salary**

% of Effort

Fringe (if applicable)

Total Cost to Gov’t

Federal Oversight






Public Health Advisor

14/6

$141,534

.005%


$707.67

Contractor Cost





$0

Travel





$0

Other Cost





$0

Total





$707.67

**The salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2020/DCB.pdf

A.15 Explanation for Program Changes or Adjustments

This is a new, mini generic sub-study submission.



A.16 Plans for Tabulation and Publication and Project Time Schedule

There are no plans for tabulation or publication to a peer reviewed journal.



A.17 Reason(s) Display of OMB Expiration Date is Inappropriate

There is no request for exemption from displaying the expiration date for OMB approval.



A.18 Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the Certification for Paperwork Reduction Act Submissions.

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