Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 498
- Locations
- 6
- Primary Endpoint
- Decisional Satisfaction
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Donna Berry, PhD, RN, FAAN, ACON
Director, The Phyllis F. Cantor Center
Dana-Farber Cancer Institute
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
Outcomes
Primary Outcomes
Decisional Satisfaction
Time Frame: Baseline to 6 months
Satisfaction with Preparation for Decision Making
Time Frame: Baseline to 1 month
Decisional Conflict
Time Frame: Baseline to 6 months
Secondary Outcomes
- Shift in decisional control preference from pre-decision to 1 month post-treatment(Baseline to 1 month)
- Resource utilization(Baseline to 6 months)