RecruitingNot ApplicableNCT04763980

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


Sponsor

University of California, San Francisco

Enrollment

72 participants

Start Date

Jan 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria31

  • 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 Criteria9

  • 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.

Interventions

OTHEREducational Intervention

Participate in educational session with health coach

OTHERGenetic Testing

Undergo genetic testing

OTHERSurvey Administration

Complete surveys throughout course of study.

OTHERProGene Artificial Intelligence (AI) Platform

AI Platform to be used by health coach during sessions

OTHERInterviews

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

View Full Details on ClinicalTrials.gov

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NCT04763980


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