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

228 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Veteran Peer Decision Coaching Session for PSA Screening?

Research shows that decision support tools, like coaching, can help men make informed choices about prostate cancer screening by increasing their knowledge and participation in decision-making. Additionally, community-based programs with educational sessions have been effective in promoting informed decision-making among high-risk groups. ^{1 2 3 4 5}

Is peer coaching for prostate cancer screening safe for humans?

The research articles provided do not contain specific safety data for peer coaching or shared decision-making interventions related to prostate cancer screening. These studies focus on the process and effectiveness of shared decision-making rather than safety concerns. ^{1 6 7 8 9}

How is the Veteran Peer Decision Coaching Session for PSA Screening different from other treatments for prostate cancer screening?

The Veteran Peer Decision Coaching Session for PSA Screening is unique because it involves peer coaching, where veterans help each other make informed decisions about prostate cancer screening. This approach emphasizes shared decision-making and informed consent, which is different from traditional methods that may not involve such personalized peer support. ^{1 5 6 9 10}

What is the purpose of this trial?

The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). Prostate cancer is commonly screen detected using PSA, a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits. The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. The investigators results will enhance understanding of the efficacy, cost-effectiveness, and sustainability of PDC interventions for SDM promotion across communication formats in the VA. Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services.

Research Team

Danil V Makarov, MD MHS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Shared decision making in prostate-specific antigen testing: the effect of a mailed patient flyer prior to an annual exam. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Decision support for men with prostate cancer: Concordance between treatment choice and tumor risk. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Coaching to support men in making informed choices about prostate cancer screening: A qualitative study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Navigating veterans with an abnormal prostate cancer screening test: a quasi-experimental study. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Promoting informed prostate cancer screening decision-making for African American men in a community-based setting. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prostate cancer intervention. Involving the patient in early detection and treatment. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

"Shared decision-making" for prostate cancer screening: Is it a marker of quality preventative healthcare? [2023]

8. England pubmed.ncbi.nlm.nih.gov

Do Men Receive Information Required for Shared Decision Making About PSA Testing? Results from a National Survey. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

National evidence on the use of shared decision making in prostate-specific antigen screening. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Helping men make an informed decision about prostate cancer screening: a pilot study of telephone counseling. [2021]