Engaging Older Adults in the NCI Clinical Trials Network Registration

Request for Approval under the Generic Clearance for the “Conference, Meeting, Workshop, and Poster Session Registration Generic Clearance (OD)”(OMB#: 0925-0740, Expiration Date: 07/31/2022)

TITLE OF INFORMATION COLLECTION: Engaging Older Adults in the NCI Clinical Trials Network Registration

PURPOSE: The purpose of the registration page is to understand who will be participating in the meeting and how to contact them if needed. The purpose of the meeting is to convene key stakeholders to discuss recommendations to increase enrollment of older adults on NCI-sponsored clinical trials and to develop a plan for implementation. The recommendations will focus on trial design, assessment of fitness to participate in clinical research, infrastructure needed to support older adult accrual, and ways to engage stakeholders including patients and caregivers. Overall meeting objectives include: 1) Identify modifiable barriers to participation of older adults in clinical trials, with an emphasis on clinician bias, and develop actionable interventions to address them. 2) Build consensus around the best approach and measures to define “fitness”/frailty in clinical research. 3) Develop a broader research plan to guide the implementation of geriatric assessments in future NCI-supported clinical trials to address gaps in research.

DESCRIPTION OF RESPONDENTS: The meeting will bring together approximately 75 experts from various related fields, including oncologists, gerontologists, statisticians, clinical trialists, and patient advocates.

TYPE OF COLLECTION: (Check all that apply)

[ ] Abstract [ ] Application

[ X ] Registration Form [ ] Other: ______________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

Name: Diane St. Germain

To assist review, please provide answers to the following question: If you are collecting name and email, then check yes for PII.

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ x ] Yes [ ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ x ] Yes [ ] No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [ x ] No

Amount: ___N/A______

Explanation for incentive: (include number of visits, etc)

ESTIMATED BURDEN HOURS and COSTS

Category of Respondent	No. of Respondents	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Individuals	80	1	5/60	7
Totals		80		7

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Individuals	7	$46.95	$328.65
Total			$328.65

*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/2019/May/oes_nat.htm#00-0000.

FEDERAL COST: The estimated annual cost to the Federal government is $2,274.32.

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Program Director	14/10	$ 159,286	.01%		$1,592.86
Administrative Asst	9/5	$ 68,146	.01%		$681.46
Contractor Cost					$0
Travel					$0
Other Cost					$0
Total					$2,274.32

**The salary in the table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/DCB.aspx

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [x ] Yes [ ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

Administration of the Instrument

How will you collect the information? (Check all that apply)

[ X ] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Survey Form

[ ] Chart Abstraction

[ ] Other, Explain

2. Will interviewers, facilitators, or research coordinators be used? [ ] Yes [ x ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

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