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 21, 2013
Last verified: October 2013

June 3, 2008
October 21, 2013
February 2007
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00692653 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Prostate Cancer
Behavioral: P4
Tailored online decision support system for prostate cancer treatment decision making
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
498
December 2009
October 2009   (final data collection date for primary outcome measure)

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
Male
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00692653
1 R01 NR009692, R01NR009692
No
Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • National Institute of Nursing Research (NINR)
  • University of Washington
Principal Investigator: Seth Wolpin, RN, PhD University of Washington
Study Director: Donna L Berry, RN, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2013

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