Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Recruiting · NCT04763980 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
Educational InterventionGenetic TestingInterviewsProGene Artificial Intelligence (AI) PlatformSurvey Administration
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.
- Prior germline genetic test.
- Age \<18 years old.
- Unable to read or answer forms.
- ENROLLING: PART 1:
- \. Contraindication to any study-related procedure or assessment.
- ENROLLING: PART 2:
- Self-reports prior germline genetic test.
- Contraindication to any study-related procedure or assessment.
Where it is running
3 locations listed across 1 US state.
- Zuckerberg San Francisco General Hospital - San Francisco, California, United States
- San Francisco Veterans Administration Medical Center - San Francisco, California, United States
- University of California San Francisco - San Francisco, California, United States