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

Metastatic Prostate Carcinoma Clinical Trial

Official title:

Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627219
• Other study ID #: 22C.423
• Status: Recruiting
• Start date: June 3, 2024
• Est. completion date: April 29, 2026

Study information

• Verified date: June 2024
• Source: Thomas Jefferson University
• Contact: Amy Leader, DrPh, MPH
• Phone: 215 955-7739
• Email: amy.leader[@]jefferson.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 29, 2026
• Est. primary completion date: April 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Prostate Carcinoma
• Prostatic Neoplasms
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Intervention

Behavioral:
• Training and Education
Undergo training and education

Other:
• Educational Intervention
Receive educational booklet

Procedure:
• Discussion
Attend discussion with peer genetic coach

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inquiries to the central number (feasibility)		Up to 1 year
Primary	Percent of callers screened and eligible to participate (feasibility)		Up to 1 year
Primary	Percent of eligible callers who enroll in the study (feasibility)		Up to 1 year
Primary	Percent who complete the endpoint assessment (feasibility)		Up to 1 year
Primary	Number and percent of men making genetic counseling appointments		Up to 1 year
Secondary	Change in decisional conflict for genetic counseling	Reported with mean and standard deviation.	Baseline up to 1 year
Secondary	Change in acceptability/attitude toward genetic counseling and testing	Reported with mean and standard deviation.	Baseline up to 1 year
Secondary	Change of genetics knowledge	Reported with mean and standard deviation	Baseline up to 1 year