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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Other: Educational Intervention
* Other: Genetic Testing
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Prior germline genetic test Age < 18 years old Unable to read or answer forms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort A (survey, genetic testing)<br>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. | Other: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Survey Administration<br>* Complete survey<br>|
| Experimental: Cohort B (educational session, survey, genetic testing)<br>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. | Other: Educational Intervention<br>* Participate in educational session with health coach<br>* Other names: Intervention, Educational;Other: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Survey Administration<br>* Complete survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent rate for germline testing | 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. | At baseline (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict scale score | 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. | At baseline and exit/follow-up visit (up to 2 days) |