NCT05958082

Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients With High-Risk Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018. In this study, consented patients will undergo a low-risk intervention of an educational session with a trained staff member on germline testing in prostate cancer and, if agreeable, subsequent germline cancer genetic testing via a commercial lab test.

Detailed description

This is a prospective, single-arm, quality improvement initiative for the use of a standardized educational intervention on germline testing in black patients with prostate cancer to improve the rates of germline genetic testing among those recommended for testing. Patients who consent to the study will undergo a one-on-one in-person education session regarding the rationale and the benefits/risks of germline testing. The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer. At the start of the session, the patient will be given a short questionnaire to assess their understanding about germline and genetic testing, along with a Family History questionnaire. Following the educational intervention, the patient will be asked to complete a short patient education and satisfaction questionnaire. If a patient wishes to proceed with testing, they will sign the standard consent to proceed with germline testing via a commercial assay. Upon a patient deciding to pursue testing, testing will consist of a prostate cancer germline panel with a commercially available blood or saliva-based assay. Upon receipt of the results, the coordinator will alert the patient's clinician, who will then share the results with the patient either in clinic or by phone. If the results show a pathogenic germline mutation, the patient will be referred to see Henry Ford Health genetics clinic for consultation with a genetics counselor. If a patient pursues genetic testing, following receipt of results, the patient's clinicians will be asked to complete a short survey on to assess how the results of germline testing affected the patient's current and future management.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Educational video	The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-07-24
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States