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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05487846
Study type Interventional
Source Thomas Jefferson University
Contact Veda Giri, MD
Phone 215-503-5253
Email veda.giri@jefferson.edu
Status Not yet recruiting
Phase N/A
Start date November 14, 2024
Completion date May 31, 2026

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