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

NCT ID: NCT04763980

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Genetic Testing

Intervention Type OTHER

Undergo genetic testing

Survey Administration

Intervention Type OTHER

Complete surveys throughout course of study.

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Participate in educational session with health coach

Genetic Testing

Intervention Type OTHER

Undergo genetic testing

Survey Administration

Intervention Type OTHER

Complete surveys throughout course of study.

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Participate in educational session with health coach

Genetic Testing

Intervention Type OTHER

Undergo genetic testing

Survey Administration

Intervention Type OTHER

Complete surveys throughout course of study.

ProGene Artificial Intelligence (AI) Platform

Intervention Type OTHER

AI Platform to be used by health coach during sessions

Interviews

Intervention Type OTHER

Participant and provider interviews will be conducted by study staff.

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Participate in educational session with health coach

Genetic Testing

Intervention Type OTHER

Undergo genetic testing

Survey Administration

Intervention Type OTHER

Complete surveys throughout course of study.

ProGene Artificial Intelligence (AI) Platform

Intervention Type OTHER

AI Platform to be used by health coach during sessions

Interviews

Intervention Type OTHER

Participant and provider interviews will be conducted by study staff.

Interventions

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Educational Intervention

Participate in educational session with health coach

Intervention Type OTHER

Genetic Testing

Undergo genetic testing

Intervention Type OTHER

Survey Administration

Complete surveys throughout course of study.

Intervention Type OTHER

ProGene Artificial Intelligence (AI) Platform

AI Platform to be used by health coach during sessions

Intervention Type OTHER

Interviews

Participant and provider interviews will be conducted by study staff.

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Genetic analysis Genetic Examination Genetic Test Questionnaire Administration ProGene AI Platform ProGene Participant interviews

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lazarex Cancer Foundation

UNKNOWN

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Kwon, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status RECRUITING

San Francisco Veterans Administration Medical Center

San Francisco, California, United States

Site Status NOT_YET_RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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UCSF Genitourinary Medical Oncology Recruitment

Role: CONTACT

Phone: 877-827-3222

Email: [email protected]

Facility Contacts

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Miriam Perales

Role: primary

UCSF Genitourinary Medical Oncology Recruitment

Role: primary

Role: backup

Other Identifiers

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NCI-2021-01027

Identifier Type: REGISTRY

Identifier Source: secondary_id

20553

Identifier Type: -

Identifier Source: org_study_id