Clinical trial · Interventional
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P4 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- P4
- description
- Participant uses P4 program before meeting with his clinician to discuss treatment options.
- interventionNames
- Behavioral: P4
- type
- NO_INTERVENTION
- label
- Usual care+
- description
- Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments.
Primary outcomes (3)
- measure
- Decisional Conflict
- timeFrame
- Baseline to 6 months
- measure
- Decisional Satisfaction
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDUnderhill 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 25344101
- DERIVEDBosco 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 23021156
- DERIVEDBerry 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 22608696