The Peer Genetic Study

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05011799
• Other study ID #: 19F.496
• Secondary ID: W81XWH1910399
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: September 28, 2024

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 149
• Est. completion date: September 28, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject
• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Behavioral:
• Cancer Educational Materials
Receive prostate cancer educational materials

Other:
• Questionnaire Administration
Ancillary studies
• Educational Intervention
Attend peer-led education sessions

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Prostate Cancer response	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