Clinical trial · Interventional
The Personal Patient Profile Decision Support for Patients With Bladder Cancer
- 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)
There is a pressing need to develop a personalized, value-based decisional tool for bladder cancer patients undergoing radical cystectomy (bladder removal) and urinary diversion to help them with communication with the physicians, shared decision making, and preparation for disease-management and follow-up care. The proposed intervention, the Personal Patient Profile - Bladder Cancer (P3-BC), will be the first intervention to address these issues. Results of this pilot randomized feasibility study will provide evidence of the feasibility and acceptability of the P3-BC and will guide further refinement of the tool for a larger experimental trial, with potential dissemination of the program via the Internet and hand-held computing devices.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P3BC | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- type
- EXPERIMENTAL
- label
- Intervention (P3-BC) Usual Care
- description
- intervention + usual care group. In addition to receiving usual care, patients will have access to the aid and related materials before consultation with the physician about cystectomy and urinary diversion.
- interventionNames
- Behavioral: P3BC
Primary outcomes (3)
- measure
- Percent of Participants Who Agree Using the Acceptability Scale
- timeFrame
- 1 month Follow-up
- description
- Percentage of participants who agreed with the statements taken from the Survey-based Acceptability Measure Acceptability is assessed with the 13-item web-based scale in addition to items designed by the research team for the 1-month follow-up to evaluate acceptability. The acceptability is defined as 80% acceptable ratings. Using well-established feasibility criteria to assess: 1) retention/drop-out rates, and 2) duration and completion rate of study assessments. The scale uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients: cystectomy for MIBC and NMIBC; * at least 18 years; * able to communicate in English; and * competent to give consent. Exclusion Criteria: \- Existence of other cancers or ongoing cancer treatment.
References
Publications (0)
Data not yet available