Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

Prostate Cancer Clinical Trial

— P4  

Official title:

Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692653
• Other study ID #: 1R01NR009692
• Secondary ID: R01NR009692
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: April 30, 2015
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• P4
Tailored online decision support system for prostate cancer treatment decision making

Locations

Country	Name	City	State
United States	VA Medical Center / Medical College of Georgia	Augusta	Georgia
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Texas Health Sciences Center at San Antonio	San Antonio	Texas
United States	Seattle Prostate Institute	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Veterans Administration Puget Sound Health Care System	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Institute of Nursing Research (NINR), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional Conflict		Baseline to 6 months	No
Primary	Decisional Satisfaction		Baseline to 6 months	No
Primary	Satisfaction with Preparation for Decision Making		Baseline to 1 month	No
Secondary	Shift in decisional control preference from pre-decision to 1 month post-treatment		Baseline to 1 month	No
Secondary	Resource utilization		Baseline to 6 months	No