Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-26 @ 1:00 AM
Study NCT ID:
NCT00815750
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2008-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 106302 | OTHER | USF IRB | View |