Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

This study has been completed.
Sponsor:
Collaborators:
University of Washington
Information provided by (Responsible Party):
Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00692653
First received: June 3, 2008
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 Intervention
Prostate Cancer
Behavioral: P4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 498
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692653

Locations
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
University of Washington
Investigators
Principal Investigator: Seth Wolpin, RN, PhD University of Washington
Study Director: Donna L Berry, RN, PhD Dana-Farber Cancer Institute
  More Information

No publications provided by Dana-Farber Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donna Berry, PhD, RN, FAAN, ACON, Director, The Phyllis F. Cantor Center, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00692653     History of Changes
Other Study ID Numbers: 1 R01 NR009692, R01NR009692
Study First Received: June 3, 2008
Last Updated: October 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Dana-Farber Cancer Institute:
Localized prostate cancer
Treatment decision making
Tailored decision aid

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014