N/A
N=24
The Personal Patient Profile Decision Support for Patients With Bladder Cancer
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05033067 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Percent of Participants Who Agree Using the Acceptability Scale — 71.4; 62.5; 62.5; 62.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P3BC (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Who Agree Using the Acceptability Scale |
71.4; 62.5; 62.5; 62.5; 62.5; 62.5 | — |
| PRIMARY Number of Participants Who Agree or Disagree With Statements on the Acceptability E-scale |
6; 2; 5; 3; 5; 3 | — |
| PRIMARY Percent of Participants Agreeing or Disagreeing With the Decision Using the Program Evaluation Scale |
0; 0; 100; 0; 14; 86 | — |
| SECONDARY Shared Decision Making Questionnaire (SDM-Q-9) |
5.43; 5.47 | — |
| SECONDARY Decisional Conflict Scale |
4.28; 4.56 | — |
| SECONDARY Brief Symptom Index (BSI-18) |
0.51; 0.15; 0.26; 0.07 | — |
| SECONDARY Decisional Regret Scale |
4.38; 4.67 | — |
| SECONDARY The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS) |
— | — |
| SECONDARY Bladder Cancer Knowledge Scale |
11.1250; 11.333 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05033067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.