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

Primary Purpose

Prostate Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Genetic Testing
Survey Administration
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >= 18 years old
  • Speak and read 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

Exclusion Criteria:

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cohort A (survey, genetic testing)

Cohort B (educational session, survey, genetic testing)

Arm Description

Patients 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. Patients may also undergo genetic testing.

Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.

Outcomes

Primary Outcome Measures

Consent rate for germline testing
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.

Secondary Outcome Measures

Decisional conflict scale score
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.

Full Information

First Posted
February 17, 2021
Last Updated
March 14, 2023
Sponsor
University of California, San Francisco
Collaborators
Lazarex Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04763980
Brief Title
Community-Based Health Coach to Improve Access to Germline Genetic Testing Among African American Men With Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Lazarex Cancer Foundation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 OBJECTIVE: I. To assess uptake of genetic testing using tailored education strategies and culturally relevant cancer resources delivered by a community-based health coach. SECONDARY OBJECTIVE: 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. TERTIARY OBJECTIVE: I. To assess the germline mutation rate among African American men with prostate cancer. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT A: Patients 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. Patients may also undergo genetic testing. COHORT B: Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A (survey, genetic testing)
Arm Type
Active Comparator
Arm Description
Patients 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. Patients may also undergo genetic testing.
Arm Title
Cohort B (educational session, survey, genetic testing)
Arm Type
Experimental
Arm Description
Patients participate in educational session with health coach over 60 minutes. Patients 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. Patients may undergo genetic testing.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Participate in educational session with health coach
Intervention Type
Other
Intervention Name(s)
Genetic Testing
Other Intervention Name(s)
genetic analysis, Genetic Examination, Genetic Test
Intervention Description
Undergo genetic testing
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete survey
Primary Outcome Measure Information:
Title
Consent rate for germline testing
Description
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.
Time Frame
At baseline (1 day)
Secondary Outcome Measure Information:
Title
Decisional conflict scale score
Description
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.
Time Frame
At baseline and exit/follow-up visit (up to 2 days)
Other Pre-specified Outcome Measures:
Title
Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing
Description
Will be determined by the sum of all alterations detected on Color genomics. Summary statistics will be obtained.
Time Frame
At baseline and exit/follow-up visit (up to 2 days)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years old Speak and read 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 Exclusion Criteria: Prior germline genetic test Age < 18 years old Unable to read or answer forms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Borno, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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