RECRUITINGINTERVENTIONAL
Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form.
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.
Who Should NOT Join This Trial:
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:
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
Educational Intervention
Participate in educational session with health coach
OTHER
Genetic Testing
Undergo genetic testing
OTHER
Survey Administration
Complete surveys throughout course of study.
OTHER
ProGene Artificial Intelligence (AI) Platform
AI Platform to be used by health coach during sessions
OTHER
Interviews
Participant and provider interviews will be conducted by study staff.
Locations (3)
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