Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation

NCT ID: NCT05487846

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-05-31

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Develop a peer-based navigation program for African American (AA) men with prostate cancer (PCA).

II. Conduct a pilot study of peer-navigated genetic evaluation vs. standard clinical care and assess feasibility of peer navigation.

SECONDARY OBJECTIVE:

I. Evaluating the intervention effects on decisional conflict and PCA genetics knowledge.

EXPLORATORY OBJECTIVE:

I. Assessing trust of the healthcare system and satisfaction with the genetic evaluation process.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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 saliva collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.

ARM II: 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.

Conditions

Metastatic Prostate Carcinoma; Stage III Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: BEHAVIORAL

Receive peer navigation services

Genetic Counseling

Intervention Type: OTHER

Receive genetic counseling

Survey Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive standard care

Genetic Counseling

Intervention Type: OTHER

Receive genetic counseling

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Patient Navigation

Receive peer navigation services

Intervention Type: BEHAVIORAL

Genetic Counseling

Receive genetic counseling

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Best Practice

Receive standard care

Intervention Type: OTHER

Genetic Counseling

Receive genetic counseling

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Patient Navigator Program; standard of care; standard therapy

Eligibility Criteria

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

• Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Leader, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Leader, DrPH, MPH

Role: CONTACT

Amy.leader@jefferson.edu

215-955-7739

Facility Contacts

Amy Leader, DrPH, MPH

Role: primary

amy.leader@jefferson.edu

215-955-7739

Amy Leader

Role: backup

Other Identifiers

JT 17263

Identifier Type: OTHER

Identifier Source: secondary_id

PC200282

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

21F.686

Identifier Type: -

Identifier Source: org_study_id