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

Not Applicable

Active, not recruiting

• Conditions: Prostate Carcinoma
• Interventions: Other: Genetic Testing; Other: Educational Intervention; Other: Survey Administration

• Registration Number: NCT04763980
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach.

SECONDARY OBJECTIVE:

I. To assess decisional conflict among African American men receiving tailored education strategies and culturally relevant cancer resources on genetic testing delivered by a community-based health coach.

TERTIARY OBJECTIVE:

I. To assess the germline mutation rate among African American men with prostate cancer.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients 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. Patients may also undergo genetic testing.

COHORT B: Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-15
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Age >= 18 years old
• Speak and read English
• Have no known cancer risk genetic mutation
• Self-identify as Black or African American
• Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines

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Exclusion Criteria

• Prior germline genetic test
• Age < 18 years old
• Unable to read or answer forms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort B (educational session, survey, genetic testing)	Survey Administration	Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.
Cohort A (survey, genetic testing)	Genetic Testing	Patients 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. Patients may also undergo genetic testing.
Cohort B (educational session, survey, genetic testing)	Educational Intervention	Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.
Cohort B (educational session, survey, genetic testing)	Genetic Testing	Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.
Cohort A (survey, genetic testing)	Survey Administration	Patients 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. Patients may also undergo genetic testing.

Primary Outcome Measures

Name	Time	Method
Consent rate for germline testing	At baseline (1 day)	The consent rate for each cohort will be defined as proportion of patients enrolled in the study who agree to undergo germline genetic testing with Color genomics. The point estimate and 90% confidence interval will be provided.

Secondary Outcome Measures

Name	Time	Method
Decisional conflict scale score	At baseline and exit/follow-up visit (up to 2 days)	The decisional conflict scale will be scored using a validated instrument. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Summary statistics with median and interquartile range will be obtained.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States