Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks

Study Overview
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Brief Summary
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The purpose of this study is to determine whether using the P3P website can increase decisional preparation and satisfaction, and decrease decisional conflict, in men deciding how to manage early stage prostate cancer.

Official Title
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Personal Patient Profile - Prostate (P3P) II: Effectiveness-Implementation Trial in Diverse Health Care Networks

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Personal Patient Profile - Prostate (P3P)
* Behavioral: Standard prostate cancer information websites


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven diagnosis of prostate cancer, T1 or T2 of any risk level Biopsy done at enrolling site Upcoming appointment with consulting specialist at enrolling study site Able to read, write, understand English Exclusion Criteria: Two or more post-biopsy specialist consults Begun treatment (or active surveillance)

Ages Eligible for Study
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Minimum Age: 18 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual patient education + standard educational websites<br> | Behavioral: Standard prostate cancer information websites<br>* Standard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics<br>|
| Experimental: Usual patient education + P3P decision support website<br> | Behavioral: Personal Patient Profile - Prostate (P3P)<br>* Website supporting informed patient decision making about prostate cancer care through tailored education and coaching<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | O'Connor, 1995, Decisional conflict scale | Change from baseline to 6-months | 
| Preparation for decision making | Graham and O'Connor, 1995, Preparation for decision making scale | 1-month after study entry | 
| Satisfaction with decision | Holmes-Rovner et al, 1996, Satisfaction with decision scale | 6-months after study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of care choice selected with self-reported influential personal preferences | Odds ratio of selecting a care option for prostate cancer concordant with avoiding prioritized side effects (XBRT or brachytherapy if concerned with sexual function; prostatectomy if concerned with bowel function; active surveillance if concerned with sexual, bowel, and/or bladder function; any treatment if not concerned with any side effect). | 6-months from study entry | 
| Net cost and benefit of the intervention | Cost to the patient will be measured in hours valued according to patient work status, income, and use of time. Benefit will be measured with Willingness to pay. | 1-week after study entry | 
| Time to treatment decision | Duration (in days) from pre-decision baseline questionnaire until patient decides on a care option for prostate cancer, either an active treatment type or active surveillance. Measured by patient recall at 6-months. | 6-months from study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Decision