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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zuckerberg San Francisco General Hospital
  San Francisco, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• San Francisco Veterans Administration Medical Center
  San Francisco, California, United States Not yet recruiting

Study contacts

• Principal investigator: Daniel Kwon, MD — University of California, San Francisco
• Study coordinator: UCSF Genitourinary Medical Oncology Recruitment
• Email: GUTrials@ucsf.edu
• Phone: 877-827-3222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.