Clinical trial NCT04763980: Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Official title: Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Lazarex Cancer Foundation
First posted: 2021-02-21
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Consent rate for germline testing
timeFrame: At baseline (1 day)
Secondary outcomes:
measure: Decisional conflict scale score
timeFrame: At baseline and exit/follow-up visit (up to 2 days)
Other outcomes:
measure: Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing
timeFrame: At baseline and exit/follow-up visit (up to 2 days)
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Daniel Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References: