Personal Patient Profile Prostate (P4) Randomized, Multisite Trial (P4)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Personal Patient Profile Prostate (P4) Randomized, Multisite Trial|
- Decisional Conflict [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
- Decisional Satisfaction [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
- Satisfaction with Preparation for Decision Making [ Time Frame: Baseline to 1 month ] [ Designated as safety issue: No ]
- Shift in decisional control preference from pre-decision to 1 month post-treatment [ Time Frame: Baseline to 1 month ] [ Designated as safety issue: No ]
- Resource utilization [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Participant uses P4 program before meeting with his clinician to discuss treatment options.
Tailored online decision support system for prostate cancer treatment decision making
No Intervention: Usual care+
Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692653
|United States, Georgia|
|VA Medical Center / Medical College of Georgia|
|Augusta, Georgia, United States, 30904|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Texas|
|University of Texas Health Sciences Center at San Antonio|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|Seattle Prostate Institute|
|Seattle, Washington, United States, 98104|
|Veterans Administration Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Seth Wolpin, RN, PhD||University of Washington|
|Study Director:||Donna L Berry, RN, PhD||Dana-Farber Cancer Institute|