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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Genetic Testing; Other: Educational Intervention; Other: Survey Administration; Other: ProGene Artificial Intelligence (AI) Platform; Other: Interviews

Detailed Description

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 (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:

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 (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).

V. 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).

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

XI. To identify reasons for declining germline testing.

TERTIARY OBJECTIVE:

I. 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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: UCSF Genitourinary Medical Oncology Recruitment; Phone Number: 877-827-3222; Email: GUTrials@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Zuckerberg San Francisco General Hospital
      • Contact: Miriam Perales; Email: Miriam.Perales@ucsf.edu
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: UCSF Genitourinary Medical Oncology Recruitment; Phone Number: 877-827-3222; Email: GUTrials@ucsf.edu
      • Contact: Email: cancertrials@ucsf.edu
      • Principal Investigator: Daniel Kwon, MD
    • San Francisco, California, United States, 94121
      • Not yet recruiting
      • San Francisco Veterans Administration Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing); 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.	Other: Genetic Testing; Undergo genetic testing; Other Names: Genetic Examination; Genetic Test; Genetic analysis; Other: Survey Administration; Complete surveys throughout course of study.; Other Names: Questionnaire Administration
Experimental: CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing); Participants 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.	Other: Genetic Testing; Undergo genetic testing; Other Names: Genetic Examination; Genetic Test; Genetic analysis; Other: Educational Intervention; Participate in educational session with health coach; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Survey Administration; Complete surveys throughout course of study.; Other Names: Questionnaire Administration
Experimental: Part 1 (educational session, survey, genetic testing); Participants 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.	Other: Genetic Testing; Undergo genetic testing; Other Names: Genetic Examination; Genetic Test; Genetic analysis; Other: Educational Intervention; Participate in educational session with health coach; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Survey Administration; Complete surveys throughout course of study.; Other Names: Questionnaire Administration; Other: ProGene Artificial Intelligence (AI) Platform; AI Platform to be used by health coach during sessions; Other Names: ProGene AI Platform; ProGene; Other: Interviews; Participant and provider interviews will be conducted by study staff.; Other Names: Participant interviews
Experimental: Part 2 Pilot (educational session, survey, genetic testing); Clinical 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.	Other: Genetic Testing; Undergo genetic testing; Other Names: Genetic Examination; Genetic Test; Genetic analysis; Other: Educational Intervention; Participate in educational session with health coach; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Survey Administration; Complete surveys throughout course of study.; Other Names: Questionnaire Administration; Other: ProGene Artificial Intelligence (AI) Platform; AI Platform to be used by health coach during sessions; Other Names: ProGene AI Platform; ProGene; Other: Interviews; Participant and provider interviews will be conducted by study staff.; Other Names: Participant interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict scale score (Initial Pilot Cohort and Part 2)	The decisional conflict scale will be scored using a validated instrument. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). Summary statistics with median and interquartile range will be obtained.	Up to 120 days
Frequency of reported facilitators to interventions (Part 1 and 2)	Participant- and provider-reported facilitators to engaging in the intervention for participants to make an informed decision about germline testing.	Up to 120 days
Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2)	Participant-reported acceptability of the intervention will be described using the TFA questionnaire. Scores on the TFA items will be averaged across all participants. Items will be scored on a 5-point scale: 1= Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5= Completely agree. All negatively worded items will be reverse-scored for a total score of 24-120. Higher scores represent greater acceptability (more positive attitudes). The mean score and standard deviation will be reported.	Up to 120 days
Number of recorded inputs into ProGene (Part 1)	The number of recorded data inputs into the ProGene platform will be reported descriptively to characterize patient-participant and health coach use of ProGene.	Up to 30 days
Proportion of patient participants who complete germline testing (Part 2)	The completion rate is defined as the proportion of patient-participants who complete germline testing within 90 days of intervention will be reported.	Up to 120 days
Mean score of adapted KnowGene germline testing knowledge survey (Part 2)	Knowledge of tumor genetic testing adapted from a validated survey from Blanchette, et al.+ select questions from a survey from Rogith, et al. will be utilized to measure the level of cancer genomic testing knowledge. "Don't know" will be scored as incorrect. The proportion of correct responses will be calculated to generate a total score between 0-100, with a higher score indicating greater knowledge. No items will be weighted. Since all items are required, we anticipate missing responses will be rare. Any missing data will be managed case-by-case post-hoc.	Up to 120 days
Mean score of genetic testing attitudes survey (Part 2)	Attitude and expectations measure for tumor genetic testing is a 17-item measure adapted from a validated survey from Blanchette, et al. including one open-ended investigator-created item. Items on the attitude scoring scale range from "Yes" = 1 and "No" or "Unsure" = 0	Up to 120 days
Proportion of individuals classified as "supporters" (Part 2)	Proportion of individuals classified as "supporters" of genetic testing	Up to 120 days
Proportion of participants who consent to study (Part 2)	Proportion of participants who consent to study among those approached as potential participants will be reported	Up to 120 days
Frequency of reported barriers to interventions (Part 2)	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 120 days
Frequency of reasons for declining testing (Part 2)	Patient-participant reported reasons for declining germline testing will be reported descriptively.	Up to 120 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing	Will be determined by the sum of all alterations detected on Color genomics. Summary statistics will be obtained.	At baseline and exit/follow-up visit (up to 2 days)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Lazarex Cancer Foundation
• Investigators: Principal Investigator: Daniel Kwon, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Genetic Techniques; Genetic Services; Diagnostic Services; Methods; Interviews as Topic; Early Intervention, Educational; Educational Status; Genetic Testing
• Other Study ID Numbers: 20553; NCI-2021-01027 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No