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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8

Intervention / Treatment
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* Behavioral: Training and Education
* Other: Educational Intervention
* Procedure: Discussion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (training, education, discussion)<br>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. | Behavioral: Training and Education<br>* Undergo training and education<br>Other: Educational Intervention<br>* Receive educational booklet<br>* Other names: Educational;Procedure: Discussion<br>* Attend discussion with peer genetic coach<br>* Other names: Discuss;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in decisional conflict for genetic counseling | Reported with mean and standard deviation. | Baseline up to 1 year | 
| Change in acceptability/attitude toward genetic counseling and testing | Reported with mean and standard deviation. | Baseline up to 1 year | 
| Change of genetics knowledge | Reported with mean and standard deviation | Baseline up to 1 year |