Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.

Detailed Description
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Background: Professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. In this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. We secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates. Methods: We plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. Each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. Trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. Men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. Data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. Additionally, medical charts will be reviewed 9 months later to assess for actual screening.

Official Title
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Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Other: You Decide
* Other: Reducing Your Risks in the Crash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 40-80 years Their physician agreed to participate in the study Seen in practice for at least one year Exclusion Criteria: Prior history of prostate cancer Presenting for acute medical visit Non-skin cancer Lung disease requiring oxygen Renal failure requiring dialysis Intensive care visit in last 6 months Need assistance with activities of daily living

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with physician For Physicians: a one-time educational session on prostate cancer and the value of shared decision making | Other: You Decide<br>* For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician For Physicians: a one-time educational session on prostate cancer and the value of shared decision making<br>|
| Active Comparator: 2<br>Highway Safety video | Other: Reducing Your Risks in the Crash<br>* Publicly available video on highway safety and reducing individual risks in a crash<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Men's understanding that prostate cancer screening requires a decision |  | baseline, post intervention, post clinical visit | 
| Men's knowledge about prostate cancer and prostate cancer screening |  | baseline, post intervention, post clinical visit | 
| Men's participation in the decision about prostate cancer screening with their clinician at their preferred level |  | baseline, post intervention, post clinical visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of a shared decision |  | post clinical visit | 
| men's intent to be screened for prostate cancer |  | post clinical visit | 
| Self reported screening |  | post visit | 
| Actual screening by chart review |  | 9 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer screening, shared decision making, prostate-specific antigen, decision making, physician-patient relations