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Evaluation of Educational Materials Promoting Informed Decision-Making About Prostate Cancer Screening—Revision—National Center for Chronic Disease and Public Health Promotion (NCDDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Prostate cancer is the second most commonly diagnosed cancer among men in the United States. Current estimates project that 234,460 new cases of prostate cancer will be diagnosed, and 27,350 men will die of this disease in 2006. 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 informed decisions about screening. The purpose of this study is to test the effectiveness of a decision aid intended as an informed decision making tool to impart knowledge and promote provider-patient discussion about prostate cancer screening.Start Printed Page 26540
The proposed study will test the effectiveness of a nationally distributed decision aid developed by CDC, and extend the existing literature on informed decision making. No past trials of prostate cancer screening decision aids have evaluated the role of primary care provider practice style. The proposed study results may inform the national discussion about informed decision-making and prostate cancer screening, and influence the clinical guidelines and primary care provider practices on prostate cancer screening. Moreover, the data may inform revisions to the current line of prostate cancer screening educational materials and influence the development of new materials.
The randomized control trial (RCT) will recruit 400 men between the ages of 50-70 years reporting for health maintenance exams with primary care providers. The intervention being tested in this project will be the decision aid entitled, Prostate Cancer Screening: A Decision Guide, used to assess the main and interactive effects of primary care provider practice style and exposure to the decision aid on prostate cancer screening.
In 2005, CDC conducted a replicated measures validation study (OMB# 0920-0651); Expiration date: 11/30/07, in which measures were validated with the target audiences to both versions of the decision aid: (1) men eligible for screening in the general population (N=200) and (2) African American men eligible for screening (N=200). The estimate of burden for the instrument is based on results from this study.
There are no costs to the respondents other than their time. The total estimated annualized burden hours are 210.
Estimated Annualized Burden
|Types of responses or kinds of respondents||Number of respondents||Number of responses per respondent||Average burden per response (in hours)|
|Men, all races aged 50-70 years||240||1||60|
|Men, all races aged 50-70 years (intervention group)||100||1||100|
|Men, all races aged 50-70 years (control group)||100||1||50|
Dated: March 14, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E6-6798 Filed 5-4-06; 8:45 am]
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