Peer navigation to support African American men with metastatic prostate cancer during genetic testing
ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation
This trial tests whether a trained peer navigator helps African American men with metastatic prostate cancer better understand and complete genetic testing compared with standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05487846 on ClinicalTrials.gov |
What this trial studies
This randomized pilot compares a peer-navigated genetic evaluation pathway to standard genetic counseling for African American men meeting NCCN criteria for testing. Participants are assigned to either a peer navigator who assists with scheduling, answers questions, aids with saliva collection, and provides result debriefing, or to standard-of-care genetic counseling and testing. The primary goals are to develop the peer-navigation program and determine feasibility of delivering navigation in this population. Secondary and exploratory measures include effects on decisional conflict, genetics knowledge, trust in the healthcare system, and satisfaction with the process.
Who should consider this trial
Good fit: African American men aged 18 or older who meet NCCN criteria for genetic testing (including metastatic disease) and can speak English are ideal candidates.
Not a fit: People who are not African American men, who do not meet NCCN testing criteria, who already completed genetic testing, or who cannot communicate in English are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase understanding of genetic testing, improve test completion, and help patients and clinicians make more informed treatment and family-risk decisions.
How similar studies have performed: Peer-navigation and patient-navigation programs have improved screening and genetic testing uptake in other cancer populations, but applying peer navigation specifically to African American men with metastatic prostate cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provide signed and dated informed consent form * English speaking only * Willing to comply with all study procedures and be available for the duration of the study * Any individual \>= 18 years old * African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age \< 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline Exclusion Criteria: * Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded * Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded
Where this trial is running
Philadelphia, Pennsylvania
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Amy Leader, DrPH, MPH — Thomas Jefferson University
- Study coordinator: Amy Leader, DrPH, MPH
- Email: Amy.leader@jefferson.edu
- Phone: 215-955-7739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.