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NCT Number: NCT05627219

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

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.

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Key information

Conditions

Metastatic Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Amy Leader, DrPh, MPH

CONTACT

[email protected]

215 955-7739

Amy Leader, DrPh, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training and Education

Behavioral

Undergo training and education

Educational Intervention

Other

Receive educational booklet

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Discussion

Procedure

Attend discussion with peer genetic coach

Other names: Discuss

Primary outcomes

  1. Number of inquiries to the central number (feasibility)

    Time frame: Up to 1 year

  2. Percent of callers screened and eligible to participate (feasibility)

    Time frame: Up to 1 year

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

    Time frame: Up to 1 year

  4. Percent who complete the endpoint assessment (feasibility)

    Time frame: Up to 1 year

  5. Number and percent of men making genetic counseling appointments

    Time frame: Up to 1 year

Secondary outcomes

  1. Change in decisional conflict for genetic counseling

    Time frame: Baseline up to 1 year

    Reported with mean and standard deviation.

  2. Change in acceptability/attitude toward genetic counseling and testing

    Time frame: Baseline up to 1 year

    Reported with mean and standard deviation.

  3. Change of genetics knowledge

    Time frame: Baseline up to 1 year

    Reported with mean and standard deviation

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Leader, DrPh, MPH

CONTACT

[email protected]

215 955-7739

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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