The Peer Genetic Study

March 13, 2024 updated by: Thomas Jefferson University

Peer-Based Intervention for Genetic Evaluation for Prostate Cancer Among African American Men: The Peer Genetic Study

This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Able to read and speak English comfortably
  • With or without a personal or family history of PCA
  • Do not need to be an established patient at CityLife Neighborhood Clinic in order to participate

Exclusion Criteria:

  • Do not read or speak English comfortably
  • Men who participated in a focus group will be excluded from participating in the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (health education)
Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months.
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Attend peer-led education sessions
Active Comparator: Arm II (cancer educational materials)
Participants receive mailed informational materials about PCA risk, family history, and genetic testing.
Other: Questionnaire Administration
Ancillary studies
Behavioral: Cancer Educational Materials
Receive prostate cancer educational materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in of decisional conflict
Time Frame: Baseline up to 2 months
Will be assessed by the 4-item Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) scale. To compute a summary decisional conflict score, the Likert-scaled responses will be averaged across the SURE item responses provided by a subject completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline and endpoint at 2-months will be calculated and group means for these changes compared between subjects randomized to receive control materials vs. those randomized to receive the peer health education intervention (i.e., by intention to treat). The significance of the difference will be evaluated at the 0.05 level using a two-sided Student's t-test. The assumptions for this test will be carefully evaluated. If the changes are substantially skewed, they will be summarized with group medians and evaluated for significant differences by the nonparametric Wilcoxon's rank sum test.
Baseline up to 2 months
Awareness of risks and benefits of genetic testing
Time Frame: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. Will investigate imbalances in these data for potential confounding of primary and exploratory endpoint analyses and investigate disparities and intervention effect modification in various subgroups of subjects.
Up to 2 months post study
Perceptions of genetic testing
Time Frame: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Up to 2 months post study
Genetic testing
Time Frame: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Up to 2 months post study
Prostate Cancer response
Time Frame: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Up to 2 months post study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

September 28, 2024

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19F.496
  • W81XWH1910399 (Other Grant/Funding Number: DOD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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