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Recruiting NCT04763980

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

No phase Interventional Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational Intervention, Genetic Testing, Survey Administration, ProGene Artificial Intelligence (AI) Platform.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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.

Interventions

  • Other Educational Intervention
    Participate in educational session with health coach
  • Other Genetic Testing
    Undergo genetic testing
  • Other Survey Administration
    Complete surveys throughout course of study.
  • Other ProGene Artificial Intelligence (AI) Platform
    AI Platform to be used by health coach during sessions
  • Other Interviews
    Participant and provider interviews will be conducted by study staff.

Primary outcome measures

  • Consent rate for germline testing (Initial Pilot Cohort and Part 2) [Time frame: At baseline (1 day)]
  • Frequency of reported barriers to interventions (Part 1) [Time frame: Up to 30 days]
Secondary outcome measures (11)
  • Decisional conflict scale score (Initial Pilot Cohort and Part 2) [Time frame: Up to 120 days]
  • Frequency of reported facilitators to interventions (Part 1 and 2) [Time frame: Up to 120 days]
  • Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2) [Time frame: Up to 120 days]
  • Number of recorded inputs into ProGene (Part 1) [Time frame: Up to 30 days]
  • Proportion of patient participants who complete germline testing (Part 2) [Time frame: Up to 120 days]
  • Mean score of adapted KnowGene germline testing knowledge survey (Part 2) [Time frame: Up to 120 days]
  • Mean score of genetic testing attitudes survey (Part 2) [Time frame: Up to 120 days]
  • Proportion of individuals classified as "supporters" (Part 2) [Time frame: Up to 120 days]
  • Proportion of participants who consent to study (Part 2) [Time frame: Up to 120 days]
  • Frequency of reported barriers to interventions (Part 2) [Time frame: Up to 120 days]
  • Frequency of reasons for declining testing (Part 2) [Time frame: Up to 120 days]

Eligibility criteria

Inclusion criteria

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 criteria

CLOSED TO ENROLLMENT: INITIAL PILOT COHORT.

  • Prior germline genetic test.
  • Age <18 years old.
  • Unable to read or answer forms.

ENROLLING: PART 1:

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • Zuckerberg San Francisco General Hospital — San Francisco
  • San Francisco Veterans Administration Medical Center — San Francisco
  • University of California San Francisco — San Francisco

Identifiers

NCT: NCT04763980 · 20553 · NCI-2021-01027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗