Prostate Cancer
Conditions
Keywords
Localized prostate cancer, Treatment decision making, Tailored decision aid
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.
Interventions
BEHAVIORALP4
Tailored online decision support system for prostate cancer treatment decision making
Sponsors
National Institute of Nursing Research (NINR)
University of Washington
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decisional Conflict | Baseline to 6 months |
| Decisional Satisfaction | Baseline to 6 months |
| Satisfaction with Preparation for Decision Making | Baseline to 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Shift in decisional control preference from pre-decision to 1 month post-treatment | Baseline to 1 month |
| Resource utilization | Baseline to 6 months |
Countries
United States
Outcome results
None listed