Navigate Study: Use of a Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Carcinoma
- Sponsor
- University of California, San Francisco
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- Consent rate for germline testing (Initial Pilot Cohort and Part 2)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
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.
Investigators
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.
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.
Outcomes
Primary Outcomes
Consent rate for germline testing (Initial Pilot Cohort and Part 2)
Time Frame: At baseline (1 day)
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.
Frequency of reported barriers to interventions (Part 1)
Time Frame: Up to 30 days
Participant- and provider-reported barriers to engaging in the intervention for participants to make an informed decision about germline testing will be reported descriptively.
Secondary Outcomes
- Decisional conflict scale score (Initial Pilot Cohort and Part 2)(Up to 120 days)
- Frequency of reported facilitators to interventions (Part 1 and 2)(Up to 120 days)
- Mean score of theoretical framework of acceptability (TFA) questionnaire (Part 1 and Part 2)(Up to 120 days)
- Frequency of reported barriers to interventions (Part 2)(Up to 120 days)
- Proportion of individuals classified as "supporters" (Part 2)(Up to 120 days)
- Proportion of participants who consent to study (Part 2)(Up to 120 days)
- Number of recorded inputs into ProGene (Part 1)(Up to 30 days)
- Proportion of patient participants who complete germline testing (Part 2)(Up to 120 days)
- Mean score of genetic testing attitudes survey (Part 2)(Up to 120 days)
- Frequency of reasons for declining testing (Part 2)(Up to 120 days)
- Mean score of adapted KnowGene germline testing knowledge survey (Part 2)(Up to 120 days)