Status:
COMPLETED
Decision Making in Unaffected First-Degree Relatives of Prostate Cancer Patients
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
40-70 years
Phase:
NA
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 heal...
Eligibility Criteria
Inclusion
- 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%).
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00815750
Start Date
August 1 2008
End Date
July 1 2014
Last Update
July 31 2014
Active Locations (2)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
2
James A. Haley VA Hospital
Tampa, Florida, United States, 33612