Clinical trial NCT00692653: Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
Official title: Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Localized prostate cancer
Treatment decision making
Tailored decision aid
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: University of Washington
First posted: 2008-06-06
Enrollment: 498
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Decisional Conflict
timeFrame: Baseline to 6 months
measure: Decisional Satisfaction
timeFrame: Baseline to 6 months
measure: Satisfaction with Preparation for Decision Making
timeFrame: Baseline to 1 month
Secondary outcomes:
measure: Shift in decisional control preference from pre-decision to 1 month post-treatment
timeFrame: Baseline to 1 month
measure: Resource utilization
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: VA Medical Center / Medical College of Georgia
state: Georgia
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center at San Antonio
state: Texas
city: Seattle
country: United States
facility: Seattle Prostate Institute
state: Washington
city: Seattle
country: United States
facility: Veterans Administration Puget Sound Health Care System
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Seth Wolpin, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Donna L Berry, RN, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.