Bladder CancerP3BCNCT05033067
The Personal Patient Profile Decision Support for Patients With Bladder Cancer
A study testing P3BC in people with Bladder Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- P3BC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2021to 31 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients: cystectomy for MIBC and NMIBC;
- at least 18 years;
- able to communicate in English; and
- competent to give consent.
Who cannot join
- Existence of other cancers or ongoing cancer treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Washington
Seattle, Washington, 98195-9472
About this study
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
- Bladder Cancer
- Being tested
- P3BC
- Keywords
- bladder cancer, shared decision making, behavioral intervention, urinary diversion
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P3BCBehavioural
Also called Personal Patient Profile - Bladder Cancer
The decisional aid will be developed to enhance patients' communication about cystectomy and urinary diversions with the clinicians, patients' decisions and preparation for self-care. Program users will be able to choose from a menu to view and print: a) summaries of their responses to inquiry questionnaire about information needed, b) selected statistics about specific side effects and self-care, and c) streamed video vignettes with patient actors of mixed cancer stages, age, sex, and race talking with a clinician about their treatment outcomes and self-care. An automatically printed 2-page output to facilitate discussion will list: 1) decision role preference; 2) the 4 highest ranked information preference sheets; and 3) a summary of personal factors plus suggested discussion topics to address with the clinician. The 2-pages will be provided to the treating physician by the research coordinator before the patient's next consultation appointment.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Intervention (P3-BC) Usual Care | Experimental | 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. Receives: Behavioral: P3BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants Who Agree Using the Acceptability Scale
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.
Measured: 1 month Follow-up
Number of Participants Who Agree or Disagree With Statements on the Acceptability E-scale
A 1-month follow-up questionnaire included 11 additional items assessing participants' perceptions of study procedures, acceptance of the intervention, and satisfaction with the decision aid. Responses were categorized to agree (scores 1-2 strongly agree/agree), or disagree (scores 3-5; strongly disagree, disagree, I don't know).
Measured: 1 month followup
Percent of Participants Agreeing or Disagreeing With the Decision Using the Program Evaluation Scale
Investigator-designed 12-items instrument to evaluate intervention participants' opinions and acceptance of study procedures and their satisfaction with the decisional aid. Responses for each item range from strongly agree (1) to strongly disagree (4), with higher scores indicating greater dissatisfaction with the intervention. Original responses (1-5 visual analogue scale) were categorized as Low (scores 1-2), Neutral (score 3), or High (scores 4-5). with higher scores indicating greater dissatisfaction with the intervention.
Measured: 1 month follow-up
Secondary outcomes (6)
Shared Decision Making Questionnaire (SDM-Q-9)
Shared decision making (SDM) was assessed by the SDMQ-9. The 9 items are rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45, higher score indicates more positive attitude towards SDM.
Measured: 1 month follow-up
Decisional Conflict Scale
Consists of 16 item scale measuring effectiveness on decision making. Items are given a score value of 0 = strongly agree, 1 = agree, 2 = neither agree nor disagree, 3= disagree, and 4 = disagree, full scale from 0 - 64 with higher total scores indicating higher decisional conflict.
Measured: 3 months follow-up
Brief Symptom Index (BSI-18)
Brief Symptom Index (BSI-18) was used psychological to assess distress. BSI-18 is a self-report 18-item instrument. Index full scale is scored .00 to 0.94 with higher scores indicating more distress.
Measured: 1 month follow-up and 3 month follow-up
Decisional Regret Scale
The Decisional Regret Scale consists of 5 item scale assessing regret of treatment decisions made. Each item scored from 1 to 5. Full scale is scored 1-25. Higher score indicates higher regret of treatment decisions.
Measured: 3 months follow-up
The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)
The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale was used to assess perceived problems with communication with providers.
The CARES - Medical Interaction Subscale includes 11 items rated on 5-point scale, where 0 represents "not at all" and 4 represents that problem occurred "very much". Total scores range from 0-44 for The CARES-MIS.
5 items were selected from The CARES-MIS, total subscale score range is 0-20, with higher scores indicating poorer perceived communication
Measured: 1 month follow-up
Bladder Cancer Knowledge Scale
A 14 investigator-designed items evaluating patients' knowledge about bladder cancer. Scores range from 1 (Completely certain that is true) to 5 (Completely certain that is false). After recording the items to 1 (true) and 0 (false) total sum score of this scale range from 0 -14, with higher scores indicating more knowledge about bladder cancer.
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start10 Jun 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Nihal E Mohamed, Icahn School of Medicine at Mount Sinai
- Investigators
- Nihal Mohamed, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033067
- Sponsor's protocol ID
- GCO 19-0269
- Other IDs
- 1R21NR018942-01A1
- Acronym
- P3BC
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2021
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).