NCT05487846

Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation

ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Develop a peer-based navigation program for African American (AA) men with prostate cancer (PCA). II. Conduct a pilot study of peer-navigated genetic evaluation vs. standard clinical care and assess feasibility of peer navigation. SECONDARY OBJECTIVE: I. Evaluating the intervention effects on decisional conflict and PCA genetics knowledge. EXPLORATORY OBJECTIVE: I. Assessing trust of the healthcare system and satisfaction with the genetic evaluation process. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: 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 saliva collection, schedule a post-test disclosure visit, and do a results and recommendations debrief. ARM II: 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.

Conditions

• Metastatic Prostate Carcinoma
• Stage III Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Interventions

Type	Name	Description
BEHAVIORAL	Patient Navigation	Receive peer navigation services
OTHER	Genetic Counseling	Receive genetic counseling
OTHER	Survey Administration	Ancillary studies
OTHER	Best Practice	Receive standard care
OTHER	Genetic Counseling	Receive genetic counseling
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-08-04
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States