Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Trial ID: NCT04763980
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-01-15
Completion date: 2027-03-31
Sponsor: University of California, San Francisco
Collaborators: Lazarex Cancer Foundation
Conditions: Prostate Carcinoma
Interventions: Educational Intervention; Genetic Testing; Survey Administration; ProGene Artificial Intelligence (AI) Platform; Interviews
Locations: Zuckerberg San Francisco General Hospital; San Francisco Veterans Administration Medical Center; University of California San Francisco
Countries: United States; United States; United States
Enrollment: 72
Age range: 18 Years - None
Sex: MALE

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 criteria:
Inclusion Criteria:

CLOSED TO ENROLLMENT: INITIAL PILOT COHORT:

Participants:

1. Age \>=18 years old.
2. Able to speak and read in English.
3. Have no known cancer risk genetic mutation.
4. Self-identify as Black or African American.
5. 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:

1. Age \>=18 years old.
2. Able to speak and read in English.
3. Able to understand study procedures and to comply with them for the entire length of the study.
4. Able to verbally consent.
5. Self-identifies as Black or African-American.
6. 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:

1. Self-identifies as a medical oncologist or genetics provider.
2. Able to speak and read in English.
3. Able to understand study procedures and to comply with them for the entire length of the study.
4. Able to verbally consent.

ENROLLING: PART 2:

Participants:

1. Age \>=18 years old.
2. Able to speak and read in English.
3. Able to understand study procedures and to comply with them for the entire length of the study.
4. Able to provide written informed consent.
5. Have no known cancer risk genetic mutation.
6. Self-identify as Black or African American.
7. Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines.
8. For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed.

Exclusion Criteria:

CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.

1. Prior germline genetic test.
2. Age \<18 years old.
3. Unable to read or answer forms.

ENROLLING: PART 1:

1\. Contraindication to any study-related procedure or assessment.

ENROLLING: PART 2:

1. Self-reports prior germline genetic test.
2. Contraindication to any study-related procedure or assessment.

Outcomes:
Consent rate for germline testing (Initial Pilot Cohort and Part 2); Frequency of reported barriers to interventions (Part 1)