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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 Start Printed Page 30918risks 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|
|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|
|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|
|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.
[FR Doc. 04-12225 Filed 5-28-04; 8:45 am]
BILLING CODE 4163-18-P