The Personal Patient Profile Decision Support for Patients With Bladder Cancer (P3BC)

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Behavioral: P3BC

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Washington
    • Seattle, Washington, United States, 98195-9472
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Intervention (P3-BC) Usual Care; 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.	Behavioral: P3BC; 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.; Other Names: Personal Patient Profile - Bladder Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	1 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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.	3 months follow-up

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Nursing Research (NINR); University of Washington
• Investigators: Principal Investigator: Nihal Mohamed, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: behavioral intervention; bladder cancer; shared decision making; urinary diversion
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: GCO 19-0269; 1R21NR018942-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal for individual participant data meta-analysis. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No