The Peer Genetic Study

Not Applicable

Active, not recruiting

• Conditions: Healthy Subject; Prostate Carcinoma
• Interventions: Behavioral: Cancer Educational Materials; Other: Educational Intervention; Other: Questionnaire Administration

• Registration Number: NCT05011799
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-08
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-18
• Primary Completion: 2023-06-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Study Completion: 2024-09-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 149

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (health education)	Educational Intervention	Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months.
Arm II (cancer educational materials)	Cancer Educational Materials	Participants receive mailed informational materials about PCA risk, family history, and genetic testing.
Arm II (cancer educational materials)	Questionnaire Administration	Participants receive mailed informational materials about PCA risk, family history, and genetic testing.
Arm I (health education)	Questionnaire Administration	Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months.

Primary Outcome Measures

Name	Time	Method
Change in of decisional conflict	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.
Awareness of risks and benefits of genetic testing	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.
Perceptions of genetic testing	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.
Genetic testing	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.
Prostate Cancer response	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.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States