04-12225. Proposed Data Collections Submitted for Public Comment and Recommendations

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Evaluation of Educational Materials Promoting Informed Decision-Making About Prostate Cancer Screening—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Prostate cancer is the second most commonly diagnosed cancer among men in the United States. In 2003, an estimated 220,900 new cases of prostate cancer was diagnosed, and approximately 28,900 men died from the disease. The effectiveness of prostate cancer screening has not been established. A number of clinical guidelines recommend that the potential risks and benefits of prostate cancer screening be explained to patients so that they may make an informed decision about screening. The purpose of this project is to evaluate the effectiveness of an informed-decision making booklet about prostate cancer screening developed by CDC.

This is a 3-year project that will be conducted in two phases of which 3 major tasks must be completed. In Task-1, the reliability and validity of a measurement instrument assessing prostate cancer knowledge and related variables will be tested. Two hundred men of all races aged 50 to 70 years and 200 African-American men aged 40 to 70 years will read the CDC booklet and complete the measurement instrument. In Task-2, 150 primary care physicians will complete a survey measuring their prostate cancer screening practices. The survey will be administered once and then again several months later. In Task-3, 400 men aged 50-70 years will take part in a randomized controlled trial. Men in the intervention group will be asked to read the CDC booklet and complete the measurement instrument tested in Task-1, and men in the control group will complete the measurement instrument without reading the CDC booklet. There is no cost to respondent except for their time.

Form name	Number of respondents	Number of responses per respondent	Avg. burden per response (in hrs.)	Total burden (in hrs.)
Phase I: Replicate Measures Validation Study
Eligibility Screener	147	1	15/60	37
Pre-visit Instrument 1	133	1	1 15/60	33
Pre-visit Instrument 2	133	1	2 30/60	67
After visit Instrument	133	1	20/60	44
Phase II: Randomized Controlled Trial
Eligibility Screener	160	1	15/60	40
Pre-visit Instrument 1	133	1	15/60	33
Pre-visit Instrument 2	67	1	30/60	34
After visit Instrument	133	1	30/60	67
Provider Practice Screener 1 (Pre-RCT)	50	1	15/60	13
Provider Practice Screener 2 (Pre-RCT)	50	1	15/60	13
Total				381
1 Includes preparation and returning the survey via mail service.
2 Includes an estimate of 25 minutes for reviewing the decision aid material.

Dated: May 20, 2004.

Joe E. Salter,

Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.