Peer Coaching for Prostate Cancer Screening

Overseen By Jerry K Thomas, MPH BA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Prostate cancer, Urinary obstruction, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of peer coaching in helping Veterans make informed decisions about prostate cancer screening. The focus is on Shared Decision Making (SDM), a process where patients and doctors collaborate on healthcare decisions, such as whether to undergo a PSA test for prostate cancer. Participants will receive either a decision aid alone or a decision aid plus coaching from a fellow Veteran (Veteran Peer Decision Coaching Session for PSA Screening). Men who are Veterans and have routine primary care appointments at the VA New York Harbor Healthcare System may be suitable candidates for this trial. As an unphased trial, this study offers Veterans a unique opportunity to contribute to research that could enhance decision-making processes in healthcare.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this peer coaching program is safe for Veterans?

Research has shown that using peer navigators for decision coaching in prostate cancer screening is generally safe. In these sessions, a trained Veteran coach helps another Veteran understand screening options. This method involves no medical procedures or drugs, so it has no physical side effects.

Previous studies have used similar peer coaching methods without reported harm. Participants typically find these sessions helpful and supportive. Since this is not a medical treatment but a supportive conversation, safety concerns are minimal. However, as with any new program, the experience can vary based on individual comfort with discussing health topics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Veteran Peer Decision Coaching Session for PSA Screening because it introduces a personalized and supportive approach to prostate cancer screening decisions. Unlike standard options that often involve patients making decisions with limited guidance, this method employs peer coaching from fellow veterans who understand the unique concerns and experiences of the participants. This peer interaction aims to enhance understanding and comfort with the decision-making process, potentially leading to more informed and satisfactory health choices. By integrating a relatable and empathetic communication style, this approach could transform how veterans engage with their healthcare decisions.

What evidence suggests that the Veteran-peer-navigator-led decision coaching is effective for promoting shared decision making in prostate cancer screening?

This trial will compare two approaches to prostate cancer screening decision-making for Veterans. Research has shown that when Veterans guide other Veterans in decision-making, the quality of choices about prostate cancer screening improves. In this trial, participants in the intervention group will receive a decision aid and additional decision coaching on PSA (prostate-specific antigen) screening from a Veteran peer-navigator decision coach. This method helps Veterans understand their options for PSA screening. PSA tests can detect prostate cancer, but they might also identify low-risk cases that don't require treatment. The guidance provided helps Veterans weigh the pros and cons, making it easier to decide what's best for them. Although specific data on the effectiveness of this approach is limited, it is believed to enhance decision-making, especially in busy healthcare environments. ^{1 2 3 6 7}

Who Is on the Research Team?

Danil V Makarov, MD MHS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

This trial is for Veterans at the VA who are considering prostate cancer screening using PSA. It's designed to help them make informed decisions about their care. Participants should be able to engage with peer navigators and attend decision coaching sessions.

Inclusion Criteria

Veteran

I am a veteran aged between 40 and 69.

I am male.

Exclusion Criteria

I am a veteran seeing my doctor for a reason other than a routine check-up.

I am a veteran diagnosed with prostate cancer.

My doctor does not treat adult men.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Veterans receive a decision aid and decision coaching on PSA screening from a Veteran-peer-navigator decision coach

Up to 3 months

1 visit (in-person or telehealth)

Control

Veteran patients receive a decision aid alone in the mail without any additional counseling

Up to 3 months

1 visit (in-person)

Follow-up

Participants are monitored for decision quality, PSA utilization, and satisfaction with decision making

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Veteran Peer Decision Coaching Session for PSA Screening

Trial Overview The study tests a program where Veteran peers guide participants through Shared Decision Making (SDM) regarding PSA screening for prostate cancer, aiming to balance benefits and risks of over-detection.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Veterans randomized to the intervention arm will receive a decision aid in the mail along with decision coaching on PSA screening from a Veteran Veteran-peer-navigator decision coach. The intervention will be administered prior to the Veteran patient's appointment with the provider.

Group II: Control Group Active Control 1 Intervention

Veteran patients in the control arm will receive a decision aid alone in the mail without any additional counseling prior to their office visit.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 295 men with prostate cancer, the use of the Personal Patient Profile-Prostate (P3P) decision support tool did not significantly increase the likelihood of pursuing guideline-concordant active surveillance for low-risk patients compared to usual care.

Factors such as Black race and having restricted treatment options were linked to lower rates of active surveillance among low-risk patients, highlighting disparities in treatment decisions rather than the effectiveness of the P3P tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision support for men with prostate cancer: Concordance between treatment choice and tumor risk. Filson, CP., Hong, F., Xiong, N., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11178112

Randomized trial of Veteran peer navigators to ... - NIH RePORTER We propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. Our results will ...

2. ctv.veeva.com ctv.veeva.com/study/randomized-trial-of-veteran-peer-navigators-to-promote-shared-decision-making-for-psa-screening

Veteran Peer Navigators to Promote Shared Decision Making ... The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making ...

3. withpower.com withpower.com/trial/phase-prostate-cancer-10-2024-1720b

Peer Coaching for Prostate Cancer Screening · Info for Participants The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for ...

4. ancora.ai ancora.ai/it/details/NCT06549036

Veteran Peer Navigators to Promote Shared Decision Making for ... The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prost.

5. smartpatients.com smartpatients.com/trials/NCT06549036

Veteran Peer Navigators to Promote Shared Decision ... The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7876807/

Randomized trial of community health worker-led decision ... In this trial, we evaluate the efficacy of a CHW-led decision-coaching program to facilitate shared decision-making for PSA screening among Black men at a ...

7. ancora.ai ancora.ai/fr/details/NCT06549036

Veteran Peer Navigators to Promote Shared Decision ... The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prost.