Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: P4

• Registration Number: NCT00692653
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 498

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P4	P4	Participant uses P4 program before meeting with his clinician to discuss treatment options.

Primary Outcome Measures

Name	Time	Method
Decisional Satisfaction	Baseline to 6 months
Satisfaction with Preparation for Decision Making	Baseline to 1 month
Decisional Conflict	Baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Shift in decisional control preference from pre-decision to 1 month post-treatment	Baseline to 1 month
Resource utilization	Baseline to 6 months

Trial Locations

Locations (6)

VA Medical Center / Medical College of Georgia; 🇺🇸 Augusta, Georgia, United States

Seattle Prostate Institute; 🇺🇸 Seattle, Washington, United States

Veterans Administration Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Health Sciences Center at San Antonio; 🇺🇸 San Antonio, Texas, United States