Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether or not participation in an experimental program called the P4 program is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant. Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes. About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.

Official Title
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Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: P4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven diagnosis of prostate cancer, stage I or II Diagnosis within the past 6 months Has appointment with a consulting specialist at one of the clinical trial sites Must be able to read and write English or Spanish at a 6th grade level Must not have begun any treatment (except watchful waiting) Must be able to complete baseline assessment before target clinician visit. Exclusion Criteria: Advanced prostate cancer Diagnosed more than 6 months ago Cannot read and write English or Spanish at a 6th grade level Does not have appointment at one of the clinical trial sites

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P4<br>Participant uses P4 program before meeting with his clinician to discuss treatment options. | Behavioral: P4<br>* Tailored online decision support system for prostate cancer treatment decision making<br>|
| No Intervention: Usual care+<br>Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict |  | Baseline to 6 months | 
| Decisional Satisfaction |  | Baseline to 6 months | 
| Satisfaction with Preparation for Decision Making |  | Baseline to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shift in decisional control preference from pre-decision to 1 month post-treatment |  | Baseline to 1 month | 
| Resource utilization |  | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Localized prostate cancer, Treatment decision making, Tailored decision aid