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Completed

NCT Number: NCT05011799

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.

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Key information

Conditions

Healthy Subject Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

35 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cancer Educational Materials

Behavioral

Receive prostate cancer educational materials

Questionnaire Administration

Other

Ancillary studies

Educational Intervention

Other

Attend peer-led education sessions

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Aug 18, 2021
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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