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

NCT05487846 | Recruiting DMC

• 3 other identifiers: 21F.686JT 17263PC200282
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Frequency of pretest genetic counseling engagement

  Compared between randomized study groups. Tested using a chi-square test. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.

  Up to 4 years

Secondary Outcomes (2)

• Mean changes in decisional conflict for genetic testing

  Up to 4 years

• Mean changes in knowledge of cancer genetics

  Up to 4 years

Other Outcomes (2)

• Healthcare system distrust

  Up to 4 years

• Satisfaction with the genetic evaluation process

  Up to 4 years

Study Arms (2)

Arm I (peer navigation)

EXPERIMENTAL

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.

Behavioral: Patient Navigation; Other: Genetic Counseling; Other: Survey Administration

Arm II (best practice)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Genetic Counseling; Other: Survey Administration

Interventions

Genetic Counseling OTHER

Receive genetic counseling

Arm I (peer navigation)

Survey Administration OTHER

Ancillary studies

Arm I (peer navigation)

Best Practice OTHER

Receive standard care

Also known as: standard of care, standard therapy

Arm II (best practice)

Patient Navigation BEHAVIORAL

Receive peer navigation services

Also known as: Patient Navigator Program

Arm I (peer navigation)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Patient Navigation; Genetic Counseling; Practice Guidelines as Topic; Standard of Care

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)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)