Combined GS Form_0925-0046-7 & -8

GENERIC SUB-STUDY SUBMISSION – 0925-0046-07 and -08

DATE OF REQUEST: December 14, 2010

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

TITLE OF SUB-STUDY:

Sub-study #7 - Prostate-Specific Antigen (PSA) Decision-Making Focus Groups

Sub-study #8 - Protocol and Information Office (PIO) External Customer Satisfaction Survey

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

TOTAL ANNUAL BURDEN APPROVED: 7050 hours

BURDEN APPROVED TO DATE: 1572 hours

BURDEN THIS REQUEST: 79 hours (sub-study #7) and 40 (sub-study #8) = 119 hours

ABSTRACT:

Sub-study #7 - The purpose of this study is to assess how individuals make medical decisions with their doctors, nurses, and other healthcare providers. Medical decision-making will be studied in the context of older males’ decision of whether or not to have the Prostate-Specific Antigen (PSA) test. This project is being overseen by the Division of Cancer Control and Population Sciences (DCCPS) and is aligned with the Office of Communications and Educations (OCE) generic clearance purposes of formative research to, “inform the design and development of NCI resources and ensure that they are appropriate and effective, and reach the intended audiences… [and to] assess the impact of resources and activities."

Sub-study #8 - The Protocol and Information Office (PIO) within the Cancer Therapy Evaluation Program (CTEP)'s Operations and Informatics Branch serves to improve the protocol development and conduct processes through the use of efficient business practices and informatics tools within the Division of Cancer Treatment and Diagnosis (DCTD). The PIO External Customer Satisfaction Survey is one means the PIO serves this purpose.

IS RACE AND ETHNICITY DATA COLLECTED AS REQUIRED?

__X__ YES (sub-study #7)

__X__NO (sub-study #8)

OBLIGATION TO RESPOND:

__X__ VOLUNTARY

______ REQUIRED TO OBTAIN OR RETAIN BENEFITS

______ MANDATORY

HOW WILL THIS SURVEY BE OFFERED?

__X____WEB SITE (sub-study #8)

__X____TELEPHONE INTERVIEW (sub-study #7 – screener)

_______ MAIL RESPONSE

_______ IN PERSON INTERVIEW

__X____OTHER: _Focus Group and Written Questionnaire (sub-study #7)

CONTACT INFORMATION:

NAME: Nina Goodman

TELEPHONE NUMBER: 301-435-7789

EMAIL ADDRESS: [email protected]