The Personal Patient Profile Decision Support for Patients With Bladder Cancer

NCT05033067 | Completed Results DMC

• 2 other identifiers: GCO 19-02691R21NR018942-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bladder Cancer

Keywords

bladder cancer; shared decision making; behavioral intervention; urinary diversion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Shared Decision Making Questionnaire (SDM-Q-9)

  1 month follow-up

• Decisional Conflict Scale

  3 months follow-up

• Brief Symptom Index (BSI-18)

  1 month follow-up and 3 month follow-up

• Decisional Regret Scale

  3 months follow-up

• The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)

  1 month follow-up

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Behavioral: P3BC

Interventions

P3BC BEHAVIORAL

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.

Also known as: Personal Patient Profile - Bladder Cancer

Intervention (P3-BC) Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients: cystectomy for MIBC and NMIBC;
• at least 18 years;
• able to communicate in English; and
• competent to give consent.

You may not qualify if:

• \- Existence of other cancers or ongoing cancer treatment.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• University of Washington: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Washington

Seattle, Washington, 98195-9472, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Nihal Mohamed, PhD
• Organization: Icahn School of Medicine at Mount Sinai

nihal.mohamed@mountsinai.org

(212) 241-8858

Study Officials

• Nihal Mohamed, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: June 10, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• 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

Locations

US (2)