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

NCT ID: NCT05958082

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Educational intervention

Patients will be asked questions about genetic testing for prostate cancer before and after an educational intervention.

Group Type: EXPERIMENTAL

Educational video

Intervention Type: BEHAVIORAL

The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer.

Interventions

Educational video

The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Men, age greater than or equal to 18 years of age.

2. Men who racially identify as black or multiracial including black

3. Diagnosis of prostate cancer of any histology.

4. Must meet NCCN guidelines for germline testing

1. Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has:

• a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or
• ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer

2. Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.

Exclusion Criteria

1. Have had prior germline testing.

2. Have somatic genetic testing that is positive for a possible germline variant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Clara Hwang

Principal Investigator, Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Cancer Pavilion

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clara Hwang, MD

Role: CONTACT

chwang2@hfhs.org

313-556-8830

Karthik Subramanian, MS

Role: CONTACT

ksubram3@hfhs.org

313-401-9815

Facility Contacts

Clara Hwang, MD

Role: primary

chwang2@hfhs.org

313-556-8830

Other Identifiers

HFH-23-01

Identifier Type: OTHER

Identifier Source: secondary_id

16491

Identifier Type: -

Identifier Source: org_study_id