Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
NCT ID: NCT00692653
Last Updated: 2015-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
498 participants
INTERVENTIONAL
2007-02-28
2009-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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P4
Participant uses P4 program before meeting with his clinician to discuss treatment options.
P4
Tailored online decision support system for prostate cancer treatment decision making
Usual care+
Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments.
No interventions assigned to this group
Interventions
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P4
Tailored online decision support system for prostate cancer treatment decision making
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
MALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Washington
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Donna Berry, PhD, RN, FAAN, ACON
Director, The Phyllis F. Cantor Center
Principal Investigators
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Seth Wolpin, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Donna L Berry, RN, PhD
Role: STUDY_DIRECTOR
Dana-Farber Cancer Institute
Locations
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VA Medical Center / Medical College of Georgia
Augusta, Georgia, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
Seattle Prostate Institute
Seattle, Washington, United States
Veterans Administration Puget Sound Health Care System
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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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.
Bosco 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.
Berry 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.
Other Identifiers
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