Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
40 Years
70 Years
Male
Prostate Cancer
Trial Information
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).
Inclusion Criteria
Inclusion/Exclusion Criteria:
- Index Patients - African American and White (non-Hispanic) index patients who have
completed definitive treatment for prostate cancer will be approached to participate.
- Index Patients Must: (a) reside in the tri-county Tampa Bay area (Hillsborough,
Pinellas and Pasco Counties, FL) to simplify logistics of arranging face-to-face
focus groups; (b) be willing to attend a focus group; (c) be able to speak, read and
write in English; and (d) be able to provide written informed consent.
- Index patients will be asked to nominate at least one male FDR (son or brother) with
no history of prostate cancer.
- Unaffected FDRs - Inclusion criteria for FDRs includes: (a) be non-Hispanic African
American or White males between the ages of 40 and 70; (b) have no self-reported
history of a diagnosis of any form of cancer (excluding non-melanoma skin cancer),
(c) have no self-reported history of prostate biopsy, or transrectal ultrasound to
investigate or rule out diagnosis of prostate cancer; (d) have not participated in
the phase (formative) portion of this study (i.e., must be "naïve" to the
intervention); (e) be able to speak, read and write English; (f) self-report access
to a DVD player; and (g) be able to provide written informed consent. FDRs with a
relative in active definitive prostate cancer treatment (i.e., surgery, radiotherapy
or chemotherapy, except for hormone therapy) or who has completed treatment in the
past 30 days will not be eligible. FDRs with multiple living relatives who been
diagnosed with prostate cancer will be excluded to reduce heterogeneity of our phase
2 sample; this exclusion criterion is expected to have a minimal influence on accrual
in light of our previous data on the percentage of men with multiple affected
relatives (less than 5%).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Aim #1 Formative, Phase 1
Outcome Description:
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.
Outcome Time Frame:
1 day
Safety Issue:
No
Principal Investigator
Clement Gwede
Investigator Role:
Principal Investigator
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Institutional Review Board
Study ID:
MCC-15320
NCT ID:
NCT00815750
Start Date:
August 2008
Completion Date:
December 2013
Related Keywords:
- Prostate Cancer
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
| James A. Haley VA Hospital | Tampa, Florida 33612 |
