Actively Recruiting
Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Led by University of California, San Francisco · Updated on 2025-12-31
72
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
L
Lazarex Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating barriers to genetic testing among African American men with prostate cancer and whether educational sessions led by community-based health coaches can improve knowledge, attitudes, and awareness about genetic testing. This study aims to better understand how to increase access to germline genetic testing in this underrepresented group. The research includes pilot phases and ongoing parts focusing on education and acceptance of genetic testing. Participants receive tailored, culturally relevant education through sessions with health coaches that last about 15 to 60 minutes, sometimes augmented by an AI chatbot called ProGene. Alongside education, participants may undergo genetic testing and complete surveys regarding their knowledge and attitudes. The study has multiple parts, including initial pilots and two ongoing parts, with some participants also undergoing interviews to assess the intervention's acceptability and barriers. During the study, participants will complete surveys at baseline and follow-up to assess changes in knowledge, attitudes, and decisional conflict about genetic testing. Researchers will collect data on consent rates, barriers, facilitators, and completion of germline testing. The study includes assessments over periods up to 120 days, with patient and provider interviews conducted at the end of the study to gather comprehensive feedback on the educational intervention and genetic testing process.
CONDITIONS
Brief Title
Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to speak and read in English
- No known cancer risk genetic mutation (Initial Pilot Cohort and Part 2)
- Self-identify as Black or African American
- Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines
- Able to understand study procedures and comply for the entire study length (Parts 1 and 2)
- Able to verbally or written consent depending on study part
- For clinic recruits in Part 2, have an oncology appointment within 3 months where germline testing will be discussed
You will not qualify if you...
- Prior germline genetic test (Initial Pilot Cohort and Part 2)
- Age under 18 years
- Unable to read or answer forms (Initial Pilot Cohort)
- Contraindication to any study-related procedure or assessment (Parts 1 and 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - About 15 to 60 minutes depending on study part
Participants engage in an educational session with a community-based health coach using tailored education strategies and culturally relevant cancer resources. The session may be in-person or remote and uses the ProGene AI platform to augment the session.
1 session (in-person or remote)
Duration - Up to 120 days
Participants complete surveys about their knowledge, attitudes, and awareness of genetic testing and technology preferences at baseline and at study exit or follow-up.
2 survey sessions (baseline and exit or follow-up)
Duration - Variable depending on participant decision
Participants may undergo germline genetic testing as part of the study.
1 visit if testing is performed
Duration - Up to 120 days
Participants are followed to assess decisional conflict, barriers and facilitators to the intervention, and completion of germline testing over time.
Periodic assessments during study period
Trial Site Locations
Total: 3 locations
1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
2
San Francisco Veterans Administration Medical Center
San Francisco, California, United States, 94121
Not Yet Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF Genitourinary Medical Oncology Recruitment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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