Grant Number:	5R21CA125428-02 Interpret this number
Primary Investigator:	Gwede, Clement
Organization:	H. Lee Moffitt Cancer Ctr & Res Inst
Project Title:	Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
Fiscal Year:	2009

DESCRIPTION (provided by applicant): The use of the prostate specific antigen (PSA) test in the general population and identifiable high-risk subgroups remains controversial, and the PSA test remains the only available test to date to detect early prostate cancer. Because of the controversy, many men who are likely to develop prostate cancer including African American men and men with a family history of prostate cancer, remain uncertain about whether to take the PSA test or not to take the test; and often make these decisions without the benefit of an informed decision aid. Male first-degree relatives (FDRs) of prostate cancer patients (particularly brothers and sons) are known to be at increased risk for the disease, yet virtually no screening informed decision making aids have been developed specifically to help these men become informed about the disease and to decide about getting the PSA test or not getting the PSA test. The specific aims of this application are to (1) develop a targeted intervention to promote informed screening decision making for FDRs; (2) conduct a small pilot study to assess the feasibility, acceptability and preliminary efficacy of the ehanced decision aid. Our study design will involve two phases. The first phase of the study will involve focus groups and interviews with prostate cancer patients and their first-degree relatives (brothers and sons) to develop the content of a supplemental digital video disc (DVD) to accompany the existing Centers for Disease Control and Prevention's (CDC) decision making booklet. The supplemental DVD will include content developed specifically to address information needs and the multiple concurrent risk factors faced by FDRs. The second phase will be a single arm pilot study to test the new enhanced intervention (EI) consisting of CDC booklet plus new supplemental DVD. We will examine feasibility, acceptability, and how well the materials work (efficacy) in FDRs. The primary analysis will include examination of pre and post-intervention changes in knowledge, risk perception, screening decision made/intentions, decisional conflict (difficulty in decision making), satisfaction with decision, and intervention use. If successfully completed, the proposed project may lead to a future R01 application for a larger randomized, controlled intervention study to test the broad usefulness of the new decision aid (compared to standard materials) in promoting informed decision making. The ultimate goal of this line of research is to reduce prostate cancer disparities and disease burden. Public Health Relevance: Prostate cancer is the most common non-skin cancer and the second leading cause of cancer deaths among American men. The greatest burden of new cases and deaths from prostate cancer is experienced by African American men and men with a positive family history of the disease. Prostate cancer can be detected early with digital rectal exam (DRE) and prostate specific antigen (PSA) blood test, yet the general use of PSA screening remains controversial and many men who are at high risk (e.g., men of African descent and men with a positive family history of prostate cancer) remain uncertain about whether to be tested or not. We seek to develop a decision aid (educational DVD) to help men with a positive family history of prostate cancer make informed decisions about testing, with the ultimate goal of reducing the burden of prostate cancer.




Perceptions of Prostate Cancer Screening Controversy and Informed Decision Making: Implications for Development of a Targeted Decision Aid for Unaffected Male First-Degree Relatives.
Authors: Gwede C.K. , Davis S.N. , Wilson S. , Patel M. , Vadaparampil S.T. , Meade C.D. , Rivers B.M. , Yu D. , Torres-Roca J. , Heysek R. , et al. .
Source: American journal of health promotion : AJHP, 2015 Jul-Aug; 29(6), p. 393-401.
EPub date: 2014-06-26.
PMID: 24968183
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Informed decision making among first-degree relatives of prostate cancer survivors: a pilot randomized trial.
Authors: Davis S.N. , Sutton S.K. , Vadaparampil S.T. , Meade C.D. , Rivers B.M. , Patel M.V. , Torres-Roca J.F. , Heysek R.V. , Spiess P. , Pow-Sang J. , et al. .
Source: Contemporary clinical trials, 2014 Nov; 39(2), p. 327-34.
EPub date: 2014-10-23.
PMID: 25465497
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