Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
Phase 1 - The purpose of this part of the research study is to conduct individual interviews
and focus groups (group discussions) to learn more about the things or behaviors that help
men to stay healthy and the decision making process for prostate cancer screening. We will
discuss men's general health concerns, knowledge, beliefs, and concerns regarding prostate
cancer and screening for prostate cancer. We will use the results from this study to
develop a decision aid to help first-degree relatives of prostate cancer patients make
informed decisions about whether to undergo testing or not to undergo testing for prostate
cancer. The new decision aid will include a digital videodisc (DVD) and an accompanying
booklet. We hope to learn from you the needs and concerns of first-degree relatives, what
information to include in the decision aid, what language to use, and the best way to
present this information.
Phase 2 - The purpose of this part of the research study is to test the usefulness and
acceptability of a new decision aid we developed specifically for first-degree relatives
(FDRs) of prostate cancer patients. We will compare the new decision aid to another widely
available decision aid that was not developed specifically for first-degree relatives. The
goal is to see if the new decision aid will change knowledge (about prostate cancer and
screening) and increase satisfaction with decision making (intention or decision made). If
we find some evidence that the new decision aid is relevant (useful) and acceptable, we will
then do a larger study with several hundred men to determine more definitively whether the
new decision aid is better than already existing general decision materials and for which
men it works best.
Because the correct decision (whether to undergo screening or not to undergo screening) is
not known at this time, the goal of decision aids is to present both (in a balanced manner)
the potential harms and benefits of screening. Therefore, this study focuses on the
informed decision making (knowledge and satisfaction with decision).
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Aim #1 Formative, Phase 1
To assess and enhance the Centers for Disease Control and Prevention (CDC)prostate cancer screening decision guides into targeted informed decision aids developed specifically for first-degree relatives of prostate cancer patients.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|
|James A. Haley VA Hospital||Tampa, Florida 33612|