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

NCT05627219 | Recruiting DMC

• 2 other identifiers: 22C.423JT 22046
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change in decisional conflict for genetic counseling

  Baseline up to 1 year

• Change in acceptability/attitude toward genetic counseling and testing

  Baseline up to 1 year

• Change of genetics knowledge

  Baseline up to 1 year

Study Arms (1)

Supportive care (training, education, 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.

Behavioral: Training and Education; Other: Educational Intervention; Procedure: Discussion

Interventions

Training and Education BEHAVIORAL

Undergo training and education

Supportive care (training, education, discussion)

Educational Intervention OTHER

Receive educational booklet

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (training, education, discussion)

Discussion PROCEDURE

Attend discussion with peer genetic coach

Also known as: Discuss

Supportive care (training, education, discussion)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men who have experience with both prostate cancer (PCA) and genetic counseling and testing, as well as peer education or navigation experience. African American men with a history of prostate cancer or with a strong family history of prostate cancer, breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer.

You may qualify if:

• 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

You may not qualify if:

• Children under the age of 18
• Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Educational Status; Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques

Study Officials

• Amy Leader, DrPh, MPH

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Leader, DrPh, MPH

CONTACT

215 955-7739; amy.leader@jefferson.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 25, 2022
• Study Start: June 3, 2024
• Primary Completion: April 29, 2026
• Study Completion: April 29, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)