Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Thomas Jefferson University
- Study ID
- NCT05487846
- Status
- Recruiting
Conditions
- Metastatic Prostate Carcinoma
- Stage III Prostate Cancer AJCC v8
- Stage IV Prostate Cancer AJCC v8
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Patient Navigation — BEHAVIORALReceive peer navigation services
- Genetic Counseling — OTHERReceive genetic counseling
- Survey Administration — OTHERAncillary studies
- Best Practice — OTHERReceive standard care
- Genetic Counseling — OTHERReceive genetic counseling
- Survey Administration — OTHERAncillary studies
Study Details
This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.
Key Dates
- Start date
- Jan 1, 2025
- Status verified
- Apr 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Arm I (peer navigation)Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in sample collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.
- Active Comparator: Arm II (best practice)Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care.
Primary Outcome Measure
Frequency of pretest genetic counseling engagement [ Time Frame: Up to 4 years ]
Central Contacts
- Amy Leader, DrPH, MPH215-955-7739
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Amy Leader Amy Leader (PRINCIPAL_INVESTIGATOR) |
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