Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04763980
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Educational Intervention — OTHER
    Participate in educational session with health coach
  • Genetic Testing — OTHER
    Undergo genetic testing
  • Survey Administration — OTHER
    Complete surveys throughout course of study.
  • ProGene Artificial Intelligence (AI) Platform — OTHER
    AI Platform to be used by health coach during sessions
  • Interviews — OTHER
    Participant and provider interviews will be conducted by study staff.

Study Details

This clinical trial studies barriers to genetic testing in African American men with prostate cancer and whether tailored, culturally relevant genetic testing education provided by a community-based health coach is beneficial in improving knowledge, attitudes, and awareness of genetic testing. Information gained from this study, may help researchers better understand and learn more about how to increase access to germline genetic testing in underrepresented populations.

Key Dates

Start date
Jan 15, 2021
Status verified
Dec 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing)
    Participants complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may also undergo genetic testing.
  • Experimental: CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing)
    Participants engage in educational session with health coach over 60 minutes. Participants also complete a survey about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences and use over 30 minutes at baseline and over 20 minutes at exit or follow up. Participants may undergo genetic testing. Participant and provider interviews will be conducted at end of study.
  • Experimental: Part 1 (educational session, survey, genetic testing)
    Participants engage in educational session lasting 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session over 15-30 minutes. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Participants may undergo genetic testing.
  • Experimental: Part 2 Pilot (educational session, survey, genetic testing)
    Clinical participants engage in educational session lasting about 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Community and clinical participants may undergo genetic testing.

Primary Outcome Measure

Consent rate for germline testing (Initial Pilot Cohort and Part 2) [ Time Frame: At baseline (1 day) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
San Francisco Veterans Administration Medical CenterSan FranciscoCalifornia94121-
University of California San FranciscoSan FranciscoCalifornia94143
UCSF Genitourinary Medical Oncology Recruitment
877-827-3222
Daniel Kwon, MD (PRINCIPAL_INVESTIGATOR)
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110
Miriam Perales

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