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

Clinicaltrials.gov ID: NCT05627219
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 30

Conditions

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

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Amy Leader, DrPh, MPH

Eligibility Criteria

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 Plan

Supportive care (training, education, discussion)

AIM 1: Peer genetic coaches undergo training and education on study.nnAIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

  • BEHAVIORAL:

    Training and Education

    Description:

    Undergo training and education
  • OTHER:

    Educational Intervention

    Description:

    Receive educational booklet
  • PROCEDURE:

    Discussion

    Description:

    Attend discussion with peer genetic coach

Outcome Measures

Primary Outcome Measures

Number of inquiries to the central number (feasibility)

Time Frame: Up to 1 year

Percent of callers screened and eligible to participate (feasibility)

Time Frame: Up to 1 year

Percent of eligible callers who enroll in the study (feasibility)

Time Frame: Up to 1 year

Percent who complete the endpoint assessment (feasibility)

Time Frame: Up to 1 year

Number and percent of men making genetic counseling appointments

Time Frame: Up to 1 year

Secondary Outcome Measures

Change in decisional conflict for genetic counseling

Time Frame: Baseline up to 1 year

Change in acceptability/attitude toward genetic counseling and testing

Time Frame: Baseline up to 1 year

Change of genetics knowledge

Time Frame: Baseline up to 1 year

Timeline

  • Last Updated
    June 10, 2024
  • Start Date
    November 25, 2022
  • Today
    May 9, 2025
  • Completion Date ( Estimated )
    April 29, 2026

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