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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692653
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : May 4, 2015
National Institute of Nursing Research (NINR)
University of Washington
Information provided by (Responsible Party):
Donna Berry, PhD, RN, FAAN, ACON, 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: P4 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
Study Start Date : February 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: P4
Participant uses P4 program before meeting with his clinician to discuss treatment options.
Behavioral: P4
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.

Primary Outcome Measures :
  1. Decisional Conflict [ Time Frame: Baseline to 6 months ]
  2. Decisional Satisfaction [ Time Frame: Baseline to 6 months ]
  3. Satisfaction with Preparation for Decision Making [ Time Frame: Baseline to 1 month ]

Secondary Outcome Measures :
  1. Shift in decisional control preference from pre-decision to 1 month post-treatment [ Time Frame: Baseline to 1 month ]
  2. Resource utilization [ Time Frame: Baseline to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692653

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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
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Institute of Nursing Research (NINR)
University of Washington
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Principal Investigator: Seth Wolpin, RN, PhD University of Washington
Study Director: Donna L Berry, RN, PhD Dana-Farber Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Donna Berry, PhD, RN, FAAN, ACON, Director, The Phyllis F. Cantor Center, Dana-Farber Cancer Institute Identifier: NCT00692653    
Other Study ID Numbers: 1R01NR009692 ( U.S. NIH Grant/Contract )
R01NR009692 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015
Keywords provided by Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute:
Localized prostate cancer
Treatment decision making
Tailored decision aid
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases