Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
P4
2 other identifiers
interventional
498
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Feb 2007
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 4, 2015
April 1, 2015
2.7 years
June 3, 2008
April 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Decisional Conflict
Baseline to 6 months
Decisional Satisfaction
Baseline to 6 months
Satisfaction with Preparation for Decision Making
Baseline to 1 month
Secondary Outcomes (2)
Shift in decisional control preference from pre-decision to 1 month post-treatment
Baseline to 1 month
Resource utilization
Baseline to 6 months
Study Arms (2)
P4
EXPERIMENTALParticipant uses P4 program before meeting with his clinician to discuss treatment options.
Usual care+
NO INTERVENTIONUsual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Institute of Nursing Research (NINR)collaborator
- University of Washingtoncollaborator
Study Sites (6)
VA Medical Center / Medical College of Georgia
Augusta, Georgia, 30904, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229, United States
Seattle Prostate Institute
Seattle, Washington, 98104, United States
Veterans Administration Puget Sound Health Care System
Seattle, Washington, 98108, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (3)
Underhill ML, Hong F, Berry DL. When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer. Health Qual Life Outcomes. 2014 Oct 25;12:159. doi: 10.1186/s12955-014-0159-3.
PMID: 25344101DERIVEDBosco JL, Halpenny B, Berry DL. Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer. Health Qual Life Outcomes. 2012 Sep 28;10:123. doi: 10.1186/1477-7525-10-123.
PMID: 23021156DERIVEDBerry DL, Wang Q, Halpenny B, Hong F. Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer. Patient Educ Couns. 2012 Aug;88(2):262-7. doi: 10.1016/j.pec.2012.04.002. Epub 2012 May 17.
PMID: 22608696DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seth Wolpin, RN, PhD
University of Washington
- STUDY DIRECTOR
Donna L Berry, RN, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, The Phyllis F. Cantor Center
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 6, 2008
Study Start
February 1, 2007
Primary Completion
October 1, 2009
Study Completion
December 1, 2009
Last Updated
May 4, 2015
Record last verified: 2015-04