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

Prostate Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763980
• Other study ID #: 20553
• Secondary ID: NCI-2021-01027
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: March 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Other:
• Educational Intervention
Participate in educational session with health coach
• Genetic Testing
Undergo genetic testing
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Lazarex Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing	Will be determined by the sum of all alterations detected on Color genomics. Summary statistics will be obtained.	At baseline and exit/follow-up visit (up to 2 days)
Primary	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.	At baseline (1 day)
Secondary	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.	At baseline and exit/follow-up visit (up to 2 days)