Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
There are two parts to this study: (1) an information gathering phase leading to development of a new decision aid (phase 1); and (2) a study to test the newly developed decision aid (phase 2).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients|
- Aim #1 Formative, Phase 1 [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Aim #2 Pilot Intervention, Phase 2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]To assess the feasibility, acceptability and preliminary efficacy of the enhanced decision aids for first degree relatives of prostate cancer patients.
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Phase I - Information Gathering||
Other: Information Gathering
An information gathering phase leading to development of a new decision aid.
|Phase 2 - Decision Aid||
Other: Decision Aid
To test the newly developed decision aid.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815750
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|James A. Haley VA Hospital|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Clement Gwede||H. Lee Moffitt Cancer Center and Research Institute|