Community-Based Health Coach for Access to Germline Genetic Testing Among African American Men With Prostate Cancer

a study on Prostate Cancer

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Daniel Kwon, MD
Headshot of Daniel Kwon
Daniel Kwon

Description

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.

Official Title

Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer

Details

PRIMARY OBJECTIVES:

  1. To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach (Initial Pilot Cohorts).

II. To assess barriers to the intervention (Part 1). III. To evaluate consent rate of germline testing among participants receiving the intervention (Part 2).

SECONDARY OBJECTIVES:

  1. 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 (Initial Pilot Cohorts).

II. To assess facilitators to the intervention (Part 1).

III. To assess acceptability of the intervention (Parts 1 and 2).

IV. To characterize patient and health coach use of ProGene (Part 1).

  1. To evaluate completion rate of germline testing among participants receiving the intervention (Part 2).

VI. To evaluate change in participant knowledge about germline testing among patient participants (Part 2).

VII. To evaluate change in participant attitudes toward germline testing among patient participants (Part 2).

VIII. To evaluate change in decisional conflict about germline testing among patient participants (Part 2).

IX. To evaluate reach of the intervention (Part 2).

  1. To evaluate barriers and facilitators to the intervention (Part 2).

XI. To identify reasons for declining germline testing.

TERTIARY OBJECTIVE:

  1. To assess the germline mutation rate among African American men with prostate cancer (Initial Pilot Cohorts)

OUTLINE: The initial pilot phase of the study has concluded. Participants are assigned to Parts 1 or 2 of current study.

CLOSED TO ENROLLMENT: INITIAL PILOT COHORT A:

Participants 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:

Participants engage in an 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.

PART 1:

Participants engage in an 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.

PART 2:

Participants in this secondary pilot engage in an 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.

Keywords

Prostate Carcinoma, Prostatic Neoplasms, Educational Intervention, Genetic Testing, ProGene Artificial Intelligence (AI) Platform, Interviews, educational session, survey, genetic testing

Eligibility

You can join if…

Open to males ages 18 years and up

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.

You CAN'T join if...

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.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Daniel Kwon, MD
    I care for hospitalized patients with advanced cancer and patients with genitourinary malignancies. My research involves improving the delivery of patient-centered care in patients with cancer. This spans decision-making, implementation, outcomes, and disparities research.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04763980
Study Type
Interventional
Participants
Expecting 72 study participants
Last Updated
Contact us about this trial