Recruiting

Peer Navigator

Sponsor:

Thomas Jefferson University

Code:

NCT05487846

Conditions

Metastatic Prostate Carcinoma

Stage III Prostate Cancer AJCC v8

Stage IV Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient Navigation

Genetic Counseling

Survey Administration

Best Practice

Genetic Counseling

Study Details

Brief summary:

This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.

Conditions

Metastatic Prostate Carcinoma

Stage III Prostate Cancer AJCC v8

Stage IV Prostate Cancer AJCC v8

Study ID

NCT05487846

Start date

Jan 1, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • English speaking only
  • Willing to comply with all study procedures and be available for the duration of the study
  • Any individual >= 18 years old
  • African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age < 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline

Exclusion Criteria:

  • Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded
  • Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Arm I (peer navigation)

Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in sample collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.

active comparator: Arm II (best practice)

Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care.

Interventions

Patient Navigation

Receive peer navigation services

Genetic Counseling

Receive genetic counseling

Survey Administration

Ancillary studies

Best Practice

Receive standard care

Genetic Counseling

Receive genetic counseling

Survey Administration

Ancillary studies

Primary outcome measure

  • Frequency of pretest genetic counseling engagement [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

Amy Leader, DrPH, MPH

215-955-7739Amy.leader@jefferson.edu

Locations

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Amy Leader, DrPH, MPH

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

Principal Investigator:

Amy Leader

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-04-14.