The Peer Genetic Study

NCT05011799 | Completed DMC

• 3 other identifiers: 19F.496W81XWH1910399JT 14300
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject; Prostate Carcinoma

Outcome Measures

Primary Outcomes (4)

• Change in of decisional conflict

  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

  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

  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

  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

Study Arms (2)

Arm I (health education)

EXPERIMENTAL

Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months.

Other: Questionnaire Administration; Other: Educational Intervention

Arm II (cancer educational materials)

ACTIVE COMPARATOR

Participants receive mailed informational materials about PCA risk, family history, and genetic testing.

Behavioral: Cancer Educational Materials; Other: Questionnaire Administration

Interventions

Cancer Educational Materials BEHAVIORAL

Receive prostate cancer educational materials

Arm II (cancer educational materials)

Questionnaire Administration OTHER

Ancillary studies

Arm I (health education); Arm II (cancer educational materials)

Educational Intervention OTHER

Attend peer-led education sessions

Arm I (health education)

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 18, 2021
• Study Start: January 8, 2020
• Primary Completion: June 30, 2023
• Study Completion: September 28, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)