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 — BEHAVIORAL
    Receive peer navigation services
  • Genetic Counseling — OTHER
    Receive genetic counseling
  • Survey Administration — OTHER
    Ancillary studies
  • Best Practice — OTHER
    Receive standard care
  • Genetic Counseling — OTHER
    Receive genetic counseling
  • Survey Administration — OTHER
    Ancillary 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

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Amy Leader, DrPH, MPH
215-955-7739
Amy Leader
Amy Leader (PRINCIPAL_INVESTIGATOR)

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