The Peer Genetic Study

Thomas Jefferson University149 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

149

Conditions

Healthy Subject Prostate Carcinoma

Interventions

Cancer Educational MaterialsBEHAVIORAL

Receive prostate cancer educational materials

Questionnaire AdministrationOTHER

Ancillary studies

Educational InterventionOTHER

Attend peer-led education sessions

Eligibility

Sex: MALEMin age: 35 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 2 months post study

Data from ClinicalTrials.gov

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