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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Prostate Carcinoma

Treatments: Other: ProGene Artificial Intelligence (AI) Platform; Other: Genetic Testing; Other: Interviews; Other: Educational Intervention; Other: Survey Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04763980

NCI-2021-01027 (Registry Identifier)

20553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

CLOSED TO ENROLLMENT - Initial Pilot Cohort A (survey, genetic testing)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Genetic Testing

CLOSED TO ENROLLMENT -Initial Pilot Cohort B (educational session, survey, genetic testing)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Educational Intervention

Other: Genetic Testing

Part 1 (educational session, survey, genetic testing)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Educational Intervention

Other: Interviews

Other: Genetic Testing

Other: ProGene Artificial Intelligence (AI) Platform

Part 2 Pilot (educational session, survey, genetic testing)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Educational Intervention

Other: Interviews

Other: Genetic Testing

Other: ProGene Artificial Intelligence (AI) Platform