NCT04763980

Community-Based Health Coach for Access to Germline Genetic Testing Among 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 OBJECTIVES: I. To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach (Initial Pilot Cohorts). II. To assess barriers to the intervention (Part 1). III. To evaluate consent rate of germline testing among participants receiving the intervention (Part 2). SECONDARY OBJECTIVES: 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 (Initial Pilot Cohorts). II. To assess facilitators to the intervention (Part 1). III. To assess acceptability of the intervention (Parts 1 and 2). IV. To characterize patient and health coach use of ProGene (Part 1). V. To evaluate completion rate of germline testing among participants receiving the intervention (Part 2). VI. To evaluate change in participant knowledge about germline testing among patient participants (Part 2). VII. To evaluate change in participant attitudes toward germline testing among patient participants (Part 2). VIII. To evaluate change in decisional conflict about germline testing among patient participants (Part 2). IX. To evaluate reach of the intervention (Part 2). X. To evaluate barriers and facilitators to the intervention (Part 2). XI. To identify reasons for declining germline testing. TERTIARY OBJECTIVE: I. To assess the germline mutation rate among African American men with prostate cancer (Initial Pilot Cohorts) OUTLINE: The initial pilot phase of the study has concluded. Participants are assigned to Parts 1 or 2 of current study. CLOSED TO ENROLLMENT: INITIAL PILOT COHORT A: 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. CLOSED TO ENROLLMENT: INITIAL PILOT COHORT B: Participants engage in an 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. PART 1: Participants engage in an 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. PART 2: Participants in this secondary pilot engage in an 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.

Conditions

• Prostate Carcinoma

Interventions

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

Timeline

• Start date: 2021-01-15
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2021-02-21
• Last updated: 2025-12-31

Locations

3 sites across 1 country: United States