Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network

Recruiting

• Conditions: Stage IV Prostate Cancer AJCC v8; Metastatic Prostate Carcinoma; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8
• Interventions: Behavioral: Training and Education; Other: Educational Intervention; Procedure: Discussion

• Registration Number: NCT05627219
• Lead Sponsor: Thomas Jefferson University

Brief Summary

This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.

Detailed Description

PRIMARY OBJECTIVES:

I. Identify and train 6 African American (AA) men as peer genetic coaches (PGCs) for the Extending Prostate Genetic Awareness, Navigation, and Delivery (EXPAND) Network. (Train peer genetic coaches) II. Conduct a feasibility study of peer genetic coaching. (Provide individual coaching)

SECONDARY OBJECTIVE:

I. Patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and change of genetics knowledge.

OUTLINE:

AIM 1: Peer genetic coaches undergo training and education on study.

AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-25
• Study Start: 2024-06-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-04-29
• Study Completion: 2026-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• AIM 1: Are 18 years old or older
• AIM 1: Are able to read and speak English comfortably
• AIM 1: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience
• AIM 2: Are 18 years old or older
• AIM 2: Are African American
• AIM 2: Are able to read and speak English comfortably
• AIM 2: Men who meet any one of the following criteria: (1) metastatic prostate cancer; (2) prostate cancer with high-risk features (T3 or higher, Gleason 8 or higher, node positive disease); (3) with or without a diagnosis of prostate cancer with strong family history (2 or more first-degree or second-degree relatives) with prostate cancer (particularly metastatic prostate cancer or died from prostate cancer), breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer

Exclusion Criteria

• Patients that do not meet the inclusion criteria
• Children under the age of 18
• Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Supportive care (training, education, discussion)	Discussion	AIM 1: Peer genetic coaches undergo training and education on study. AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.
Supportive care (training, education, discussion)	Training and Education	AIM 1: Peer genetic coaches undergo training and education on study. AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.
Supportive care (training, education, discussion)	Educational Intervention	AIM 1: Peer genetic coaches undergo training and education on study. AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Primary Outcome Measures

Name	Time	Method
Number and percent of men making genetic counseling appointments	Up to 1 year
Percent of eligible callers who enroll in the study (feasibility)	Up to 1 year
Percent of callers screened and eligible to participate (feasibility)	Up to 1 year
Percent who complete the endpoint assessment (feasibility)	Up to 1 year
Number of inquiries to the central number (feasibility)	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Change in decisional conflict for genetic counseling	Baseline up to 1 year	Reported with mean and standard deviation.
Change in acceptability/attitude toward genetic counseling and testing	Baseline up to 1 year	Reported with mean and standard deviation.
Change of genetics knowledge	Baseline up to 1 year	Reported with mean and standard deviation

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States