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Behavioral Intervention
Peer Coaching for Prostate Cancer Screening
N/A
Waitlist Available
Led By Danil V Makarov, MD MHS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veteran patient participants aged 40-69 years old
Male
Must not have
Veteran Patients with a prior diagnosis of prostate cancer (ICD-10-CM C61)
Providers who do not treat adult male patients (e.g. OB/Gyns, pediatricians)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 3
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a program led by Veteran peers to help Veterans make decisions about prostate cancer screening. The program aims to improve the quality of care by promoting Shared Decision Making (SDM) for PSA
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves decision coaching rather than medical treatment, traditional physical side effects are not expected. However, participants may experience stress or anxiety during the decision-making process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran aged between 40 and 69.
Select...
I am male.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am a veteran diagnosed with prostate cancer.
Select...
My doctor does not treat adult men.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Decision Quality Score
Decisional Conflict
Measure of Informed Choice Attitudes Scale
+3 moreSecondary study objectives
Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness (COMRADE)
Decision Self-Efficacy
Decisional Regret Scale
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 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 GroupActive Control1 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,443 Total Patients Enrolled
15 Trials studying Prostate Cancer
8,751 Patients Enrolled for Prostate Cancer
Danil V Makarov, MD MHSPrincipal InvestigatorVA NY Harbor Healthcare System, New York, NY
1 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Prostate Cancer
58 Patients Enrolled for Prostate Cancer