Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04763980
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Lazarex Cancer Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Other: Educational Intervention Other: Genetic Testing Other: Survey Administration Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cohort A (survey, genetic testing)
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.
Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test

Other: Survey Administration
Complete survey

Experimental: Cohort B (educational session, survey, 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.
Other: Educational Intervention
Participate in educational session with health coach
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test

Other: Survey Administration
Complete survey




Primary Outcome Measures :
  1. Consent rate for germline testing [ 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.


Secondary Outcome Measures :
  1. Decisional conflict scale score [ Time Frame: At baseline and exit/follow-up visit (up to 2 days) ]
    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.


Other Outcome Measures:
  1. Highly penetrant germline genetic mutation rate and variants of unknown significance among all participants who undergo germline testing [ Time Frame: At baseline and exit/follow-up visit (up to 2 days) ]
    Will be determined by the sum of all alterations detected on Color genomics. Summary statistics will be obtained.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763980


Contacts
Layout table for location contacts
Contact: Sylvia Zhang (415) 514-3601 Sylvia.Zhang@ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Sylvia Zhang    415-514-3601    sylvia.zhange@ucsf.edu   
Principal Investigator: Hala Borno, MD         
Sponsors and Collaborators
University of California, San Francisco
Lazarex Cancer Foundation
Investigators
Layout table for investigator information
Principal Investigator: Hala Borno, MD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04763980    
Other Study ID Numbers: 20553
NCI-2021-01027 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases