Community health coach program to improve access to germline genetic testing for African American men with prostate cancer

Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer

This project will test whether culturally tailored education from a community-based health coach helps African American men with advanced prostate cancer understand and use germline genetic testing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 3 sites (San Francisco, California and 2 other locations)
• Trial ID: NCT04763980 on ClinicalTrials.gov

What this trial studies

This interventional pilot uses community-based health coaches to deliver culturally relevant, tailored education about germline genetic testing to African American men with regional, advanced, or metastatic prostate cancer. Participants receive education, complete surveys, and may be offered germline testing, with use of the ProGene AI platform to support interactions and data collection. The study measures uptake, consent and completion rates, changes in knowledge and attitudes, decisional conflict, and identifies barriers and facilitators through interviews. Work is conducted at UCSF-affiliated sites in San Francisco with mixed-methods evaluation across initial pilot cohorts and subsequent parts of the study.

Who should consider this trial

Good fit: African American men age 18 or older with regional, advanced, or metastatic prostate cancer who speak English and can provide informed consent are ideal candidates.

Not a fit: People without prostate cancer, individuals who do not identify as Black/African American, or those who already have a known pathogenic germline mutation are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could increase germline testing uptake among African American men with prostate cancer, improving treatment decision-making and family risk awareness.

How similar studies have performed: Previous work using patient navigation and culturally tailored education has improved genetic testing uptake in some underserved groups, but combining community health coaches with AI support like ProGene is a relatively novel approach.

Eligibility criteria

Inclusion Criteria:

CLOSED TO ENROLLMENT: INITIAL PILOT COHORT:

Participants:

1. Age \>=18 years old.
2. Able to speak and read in English.
3. Have no known cancer risk genetic mutation.
4. Self-identify as Black or African American.
5. Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines.

ENROLLING: PART 1:

Participants:

1. Age \>=18 years old.
2. Able to speak and read in English.
3. Able to understand study procedures and to comply with them for the entire length of the study.
4. Able to verbally consent.
5. Self-identifies as Black or African-American.
6. Self-reports a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer.

Note: Participants may or may not have had germline testing in the past, as a range of experiences is valuable for holistic feedback.

Providers:

1. Self-identifies as a medical oncologist or genetics provider.
2. Able to speak and read in English.
3. Able to understand study procedures and to comply with them for the entire length of the study.
4. Able to verbally consent.

ENROLLING: PART 2:

Participants:

1. Age \>=18 years old.
2. Able to speak and read in English.
3. Able to understand study procedures and to comply with them for the entire length of the study.
4. Able to provide written informed consent.
5. Have no known cancer risk genetic mutation.
6. Self-identify as Black or African American.
7. Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines.
8. For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed.

Exclusion Criteria:

CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.

1. Prior germline genetic test.
2. Age \<18 years old.
3. Unable to read or answer forms.

ENROLLING: PART 1:

1\. Contraindication to any study-related procedure or assessment.

ENROLLING: PART 2:

1. Self-reports prior germline genetic test.
2. Contraindication to any study-related procedure or assessment.

Where this trial is running

San Francisco, California and 2 other locations

• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)
• San Francisco Veterans Administration Medical Center — San Francisco, California, United States (Not_yet_recruiting)
• University of California San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Daniel Kwon, MD — University of California, San Francisco
• Study coordinator: UCSF Genitourinary Medical Oncology Recruitment

Conditions Prostate Carcinoma