Peer Navigation for Prostate Cancer

Overseen By Amy Leader, DrPH, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Children, Understanding issues, Significant anxiety

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a peer navigator helps African American men with metastatic prostate cancer better understand and engage in genetic testing. The study compares two groups: one receiving assistance from a peer navigator and the other following standard care procedures. Peer navigators guide patients through the genetic testing process, including scheduling appointments and explaining results. Suitable participants have prostate cancer that has spread and a family history of related cancers. As an unphased trial, this study allows participants to contribute to research that may enhance support systems for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on helping you understand genetic testing with the help of a peer navigator.

What prior data suggests that peer navigation is safe for patients with metastatic prostate cancer?

Research shows that having a patient navigator is safe and helpful for cancer patients. Studies indicate that a peer navigator can assist prostate cancer patients by facilitating access to care and understanding genetic testing. As patient navigation is a supportive service rather than a medical treatment, it poses no known safety risks. It aids patients in managing their care, which can reduce stress and improve outcomes.

Furthermore, research has found that patients receiving navigation support often experience better survival rates and access to advanced care. This demonstrates that patient navigation is not only safe but also effective in guiding patients through complex medical processes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using peer navigation for prostate cancer because it adds a personal touch to the standard genetic evaluation process. Unlike traditional methods that rely solely on standard care and genetic counseling, peer navigation involves someone who has been through the process themselves, offering support and guidance. This approach can help patients feel more comfortable and informed during genetic testing by assisting with scheduling, addressing concerns, and explaining results. The hope is that this method will improve patient experience and engagement, leading to better outcomes in managing prostate cancer.

What evidence suggests that having a peer navigator is effective for helping African American men with metastatic prostate cancer understand the genetic testing process?

Research has shown that a patient navigator can greatly improve cancer treatment outcomes. In one study, 70% of patients who received assistance from a patient navigator began their cancer treatment more effectively. Another study found that patient navigation helped identify prostate cancer progression in many patients, allowing for timely treatment. In this trial, participants in Arm I will receive assistance from a peer navigator during genetic evaluation processes, which helps patients access advanced care, such as genetic testing and clinical trials, crucial for creating personalized treatment plans. For prostate cancer, patient navigation keeps more treatment options open and prevents unnoticed cancer progression. Overall, patient navigation is a promising way to ensure patients receive the best possible care. ^{1 2 3 4 6}

Who Is on the Research Team?

Amy Leader, DrPH, MPH

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for English-speaking African American men with metastatic prostate cancer who meet specific criteria, such as certain cancer stages or family history of related cancers. Participants must be willing to follow study procedures and be available throughout the study.

Inclusion Criteria

Provide signed and dated informed consent form

English speaking only

I am willing and able to follow the study rules and attend all required visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Evaluation

Participants undergo genetic evaluation with or without peer navigation support

Up to 4 years

Multiple visits as needed for counseling and testing

Follow-up

Participants are monitored for changes in knowledge, decisional conflict, and satisfaction with the genetic evaluation process

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview The trial tests if a trained peer navigator can help these patients better understand and navigate genetic testing compared to standard approaches without a peer navigator. The focus is on improving engagement in the genetic evaluation process.

How Is the Trial Designed?

Group I: Arm I (peer navigation) Experimental Treatment 3 Interventions

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 II: Arm II (best practice) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063100/

Patient Navigation in Cancer Treatment: A Systematic Review Amongst studies focused on cancer treatment initiation, 70% found a significant improvement in treatment initiation amongst patients who were enrolled in ...

2. jons-online.com jons-online.com/issues/2021/november-2021-vol-12-no-11/patient-navigation-helps-detect-prostate-cancer-progression

Patient Navigation Helps Detect Prostate Cancer Progression Results: Data at 9 months showed 62 of 229 PCa patients were detected to have cancer progression through the newly structured patient navigation system.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella ...

4. preveta.com preveta.com/prostate-cancer-navigation/

Prostate Cancer Navigation Patient navigation keeps more treatment options available for prostate cancer patients. Without consistent monitoring and check-ins, the cancer can progress ...

5. cancerletter.com cancerletter.com/guest-editorial/20220805_4/

Patient navigation improves outcomes and addresses ... Research shows that cancer patients who receive navigation have improved survival, access to advanced care like clinical trials, and services like genetic ...

6. accc-cancer.org accc-cancer.org/home/learn/comprehensive-cancer-care-services/patient-navigation

Patient Navigation The importance of care coordination in managing the adverse effects of cancer treatment and navigating patient challenges such as emotional distress, isolation, ...