Combined Generic Sub-study Form #5 and #6

GENERIC SUB-STUDY SUBMISSION – 0925-0046-05 and -06

DATE OF REQUEST: November 5, 2010

SUB AGENCY (I/C): NIH/NCI/OCE

TITLE OF SUB-STUDY:

Sub-study #5 - Testing of Messages for an NIH Clinical Trial Public Awareness Campaign

Sub-study #6 - Survey to Assess Communications Designed to Raise Awareness of Clinical

Research

GENERIC CLEARANCE UNDER OMB #0925-0046 EXP. DATE: 2/28/2013

TOTAL ANNUAL BURDEN APPROVED: 7050 hours

BURDEN APPROVED TO DATE: 1204 hours

BURDEN THIS REQUEST: 217 hours (sub-study #5) and 151 (sub-study #6) = 368 hours

ABSTRACT:

The goal of the awareness campaign is to show the benefits of clinical trials and the importance of NIH-supported clinical research for the public’s health, and highlight the need for clinical trial participants. The challenge of recruiting research participants has serious implications for the success or failure of research. Data indicates that low patient participation and failure to enroll directly impacts clinical trials. In an effort to increase public awareness about clinical trials, particularly treatment trials, the National Cancer Institute’s Office of Market Research and Evaluation (OMRE) will conduct message testing research to inform the campaign planning.

The objectives of this research task is to explore differences in target audiences’ attitudes toward and understanding of treatment clinical trials; test messages about clinical trial participation to assess comprehension, relevance, benefits, and credibility; explore differences in target audiences’ reactions to the messages; confirm that there are no negative interpretations or reactions to the messages; and assess audiences’ preferred channels.

In sub-study #5, 12 focus groups (maximum of 96 respondents) will be divided among three markets that are geographically dispersed. The focus group target audiences include persons who have a family history of a serious illness that has limited standard care, caregivers/family members of persons with long term chronic/terminal illness, persons with long term, chronic/terminal illness, cancer survivors, and the general public.

In sub-study #6, NCI proposes conducting a self-administered web-based panel survey with two target audiences: 1) 450 people from the general public, oversampling for African Americans, as well as including a sub-group of individuals who suffer from serious health conditions; and 2) 150 members of the medical community.

IS RACE AND ETHNICITY DATA COLLECTED AS REQUIRED?

__X____YES _____NO_______N/A

OBLIGATION TO RESPOND:

__X___ VOLUNTARY

______ REQUIRED TO OBTAIN OR RETAIN BENEFITS

______ MANDATORY

HOW WILL THIS SURVEY BE OFFERED?

__X___ WEB SITE (sub-study #6)

_____ TELEPHONE INTERVIEW

_____ MAIL RESPONSE

_____ IN PERSON INTERVIEW

__X___ OTHER: _Focus Groups__(sub-study #5)_

CONTACT INFORMATION:

NAME: Nina Goodman

TELEPHONE NUMBER: 301-435-7789

EMAIL ADDRESS: [email protected]

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