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
2 other identifiers
interventional
72
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
February 17, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
December 31, 2025
December 1, 2025
6.2 years
February 17, 2021
December 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Consent rate for germline testing (Initial Pilot Cohort and Part 2)
The consent rate for each cohort will be defined as proportion of patients enrolled in the study who agree to undergo germline genetic testing with Color genomics. The point estimate and 90% confidence interval will be provided.
At baseline (1 day)
Frequency of reported barriers to interventions (Part 1)
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
Up to 30 days
Secondary Outcomes (11)
Decisional conflict scale score (Initial Pilot Cohort and Part 2)
Up to 120 days
Frequency of reported facilitators to interventions (Part 1 and 2)
Up to 120 days
Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2)
Up to 120 days
Number of recorded inputs into ProGene (Part 1)
Up to 30 days
Proportion of patient participants who complete germline testing (Part 2)
Up to 120 days
- +6 more secondary outcomes
Other Outcomes (1)
Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing
At baseline and exit/follow-up visit (up to 2 days)
Study Arms (4)
CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing)
ACTIVE COMPARATORParticipants 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. Participants may also undergo genetic testing.
CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing)
EXPERIMENTALParticipants engage in educational session with health coach over 60 minutes. Participants 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. Participants may undergo genetic testing. Participant and provider interviews will be conducted at end of study.
Part 1 (educational session, survey, genetic testing)
EXPERIMENTALParticipants engage in educational session lasting 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session over 15-30 minutes. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Participants may undergo genetic testing.
Part 2 Pilot (educational session, survey, genetic testing)
EXPERIMENTALClinical participants engage in educational session lasting about 15-30 minutes with health coach in-person or remotely who will be using a ProGene chatbot to augment the session. Participants also complete surveys about knowledge of, attitudes towards, and awareness of genetic testing and technology preferences. Community and clinical participants may undergo genetic testing.
Interventions
AI Platform to be used by health coach during sessions
Participate in educational session with health coach
Undergo genetic testing
Complete surveys throughout course of study.
Participant and provider interviews will be conducted by study staff.
Eligibility Criteria
You may qualify if:
- 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.
- +16 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Lazarex Cancer Foundationcollaborator
Study Sites (3)
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
San Francisco Veterans Administration Medical Center
San Francisco, California, 94121, United States
University of California San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Kwon, MD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2021
First Posted
February 21, 2021
Study Start
January 15, 2021
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
December 31, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share