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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.
 
ClinicalTrials.gov Identifier: NCT00692653
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : May 4, 2015
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
University of Washington
Information provided by (Responsible Party):
Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 6, 2008
Last Update Posted Date May 4, 2015
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
  • Decisional Conflict [ Time Frame: Baseline to 6 months ]
  • Decisional Satisfaction [ Time Frame: Baseline to 6 months ]
  • Satisfaction with Preparation for Decision Making [ Time Frame: Baseline to 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
  • Decisional Conflict [ Time Frame: Baseline to 6 months ]
  • Satisfaction with Preparation for Decision Making [ Time Frame: Baseline to 6 months ]
  • Decisional Satisfaction [ Time Frame: Baseline to 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
  • Shift in decisional control preference from pre-decision to 1 month post-treatment [ Time Frame: Baseline to 1 month ]
  • Resource utilization [ Time Frame: Baseline to 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
Official Title  ICMJE Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Behavioral: P4
Tailored online decision support system for prostate cancer treatment decision making
Study Arms  ICMJE
  • Experimental: P4
    Participant uses P4 program before meeting with his clinician to discuss treatment options.
    Intervention: Behavioral: P4
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2008)
498
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00692653
Other Study ID Numbers  ICMJE 1R01NR009692( U.S. NIH Grant/Contract )
R01NR009692 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • National Institute of Nursing Research (NINR)
  • University of Washington
Investigators  ICMJE
Principal Investigator: Seth Wolpin, RN, PhD University of Washington
Study Director: Donna L Berry, RN, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP