Status:
RECRUITING
Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Lazarex Cancer Foundation
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
NA
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 h...
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 Coho...
Eligibility Criteria
Inclusion
- 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
- CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.
- Prior germline genetic test.
- Age \<18 years old.
- Unable to read or answer forms.
- ENROLLING: PART 1:
- 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.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04763980
Start Date
January 15 2021
End Date
March 31 2027
Last Update
December 31 2025
Active Locations (3)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
2
San Francisco Veterans Administration Medical Center
San Francisco, California, United States, 94121
3
University of California San Francisco
San Francisco, California, United States, 94143