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
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ CLOSED TO ENROLLMENT: INITIAL PILOT COHORT:

⁃ Participants:

• Age \>=18 years old.

• Able to speak and read in 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.

⁃ ENROLLING: PART 1:

⁃ Participants:

• Age \>=18 years old.

• Able to speak and read in English.

• Able to understand study procedures and to comply with them for the entire length of the study.

• Able to verbally consent.

• Self-identifies as Black or African-American.

• 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:

• Self-identifies as a medical oncologist or genetics provider.

• Able to speak and read in English.

• Able to understand study procedures and to comply with them for the entire length of the study.

• Able to verbally consent.

⁃ ENROLLING: PART 2:

⁃ Participants:

• Age \>=18 years old.

• Able to speak and read in English.

• Able to understand study procedures and to comply with them for the entire length of the study.

• Able to provide written informed consent.

• 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 NCCN guidelines.

• For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed.

Locations
United States
California
San Francisco Veterans Administration Medical Center
NOT_YET_RECRUITING
San Francisco
University of California San Francisco
RECRUITING
San Francisco
Zuckerberg San Francisco General Hospital
NOT_YET_RECRUITING
San Francisco
Contact Information
Primary
Lauren Trihy
Lauren.Trihy@ucsf.edu
877-827-3222
Time Frame
Start Date: 2021-01-15
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 72
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Lazarex Cancer Foundation

This content was sourced from clinicaltrials.gov