Community-Based Health Coach to Improve Access to Germline Genetic Testing among African American Men with Prostate Cancer, The Navigate Study
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.
Inclusion Criteria
- PREVIOUS PILOT STUDY: Age >= 18 years old
- PREVIOUS PILOT STUDY: Speak and read English
- PREVIOUS PILOT STUDY: Have no known cancer risk genetic mutation
- PREVIOUS PILOT STUDY: Self-identify as Black or African American
- PREVIOUS PILOT STUDY: Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines
- CURRENT STUDY - PART 1 PATIENTS: Age ≥ 18 years old
- CURRENT STUDY - PART 1 PATIENTS: Able to speak and read in English.
- CURRENT STUDY - PART 1 PATIENTS: Able to understand study procedures and to comply with them for the entire length of the study.
- CURRENT STUDY - PART 1 PATIENTS: Able to verbally consent.
- CURRENT STUDY - PART 1 PATIENTS: Self-identifies as Black or African-American.
- CURRENT STUDY - PART 1 PATIENTS: Self-reports a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer.
- CURRENT STUDY - PART 1 PATIENTS: Note: patients may or may not have had germline testing in the past, as a range of experiences is valuable for holistic feedback.
- CURRENT STUDY - PART 1 PROVIDERS: Self-identifies as a medical oncologist or genetics provider.
- CURRENT STUDY - PART 1 PROVIDERS: Able to speak and read in English.
- CURRENT STUDY - PART 1 PROVIDERS: Able to understand study procedures and to comply with them for the entire length of the study.
- CURRENT STUDY - PART 1 PROVIDERS: Able to verbally consent.
- CURRENT STUDY - PART 2: Age > 18 years old
- CURRENT STUDY - PART 2: Able to speak and read in English
- CURRENT STUDY - PART 2: Able to understand study procedures and to comply with them for the entire length of the study.
- CURRENT STUDY - PART 2: Able to provide written informed consent.
- CURRENT STUDY - PART 2: Have no known cancer risk genetic mutation
- CURRENT STUDY - PART 2: Self-identify as Black or African American
- CURRENT STUDY - PART 2: Self-report a diagnosis of regional (lymph node positive), advanced, or metastatic prostate cancer per NCCN guidelines
- CURRENT STUDY - PART 2: For patients recruited from the clinic: Presence of an oncology appointment within 3 months where germline testing will be discussed
Exclusion Criteria
- PREVIOUS PILOT STUDY: Prior germline genetic test
- PREVIOUS PILOT STUDY: Age < 18 years old
- PREVIOUS PILOT STUDY: Unable to read or answer forms
- CURRENT STUDY - PART 1: Contraindication to any study-related procedure or assessment.
- CURRENT STUDY - PART 2: Self-reports prior germline genetic test
- CURRENT STUDY - PART 2: Contraindication to any study-related procedure or assessment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04763980.
Locations matching your search criteria
United States
California
San Francisco
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. (PREVIOUS PILOT STUDY)
II. To assess barriers to the intervention. (CURRENT STUDY - PART 1)
III. To evaluate consent rate of germline testing among patient participants receiving the intervention. (CURRENT STUDY - PART 2)
SECONDARY OBJECTIVES:
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. (PREVIOUS PILOT STUDY)
II. To assess facilitators to the intervention. (CURRENT STUDY - PART 1)
III. To assess acceptability of the intervention. (CURRENT STUDY - PART 1)
IV. To characterize patient and health coach use of ProGene. (CURRENT STUDY - PART 1)
V. To evaluate completion rate of germline testing among patient participants receiving the intervention. (CURRENT STUDY - PART 2)
VI. To evaluate acceptability of the intervention among patient participants. (CURRENT STUDY - PART 2)
VII. To evaluate change in participant knowledge about germline testing among patient participants. (CURRENT STUDY - PART 2)
VIII. To evaluate change in participant attitudes toward germline testing among patient participants. (CURRENT STUDY - PART 2)
IX. To evaluate change in decisional conflict about germline testing among patient participants. (CURRENT STUDY - PART 2)
X. To evaluate reach of the intervention. (CURRENT STUDY - PART 2)
XI. To evaluate barriers and facilitators to the intervention. (CURRENT STUDY - PART 2)
XII. To identify reasons for declining germline testing. (CURRENT STUDY - PART 2)
TERTIARY OBJECTIVE:
I. To assess the germline mutation rate among African American men with prostate cancer. (PREVIOUS PILOT STUDY)
OUTLINE:
PREVIOUS PILOT STUDY (NO LONGER ENROLLING - 04/04/2025): 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 and genetic counseling if they receive positive results.
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 also undergo genetic testing and genetic counseling if they receive positive results.
CURRENT STUDY (AS OF 12/04/2025):
PART 1: Patients attend a session over 15-30 minutes with a health coach that provides tailored education strategies, delivers culturally relevant cancer resources for patient participants, and facilitates patient interactions with the ProGene artificial intelligence (AI) assistant.
PART 2: Patients attend a session over 15-30 minutes with a health coach that provides tailored education strategies, delivers culturally relevant cancer resources for patient participants, and facilitates patient interactions with the ProGene AI assistant. Patients may also undergo genetic testing and genetic counseling if they receive positive results.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorDaniel Hyuck-Min Kwon
- Primary ID20553
- Secondary IDsNCI-2021-01027, 20-30195
- ClinicalTrials.gov IDNCT04763980