Clinical trial NCT05033067: The Personal Patient Profile Decision Support for Patients With Bladder Cancer
Official title: The Personal Patient Profile Decision Support for Patients With Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
shared decision making
behavioral intervention
urinary diversion
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of Washington
name: National Institute of Nursing Research (NINR)
First posted: 2021-09-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Acceptability E-scale
timeFrame: Baseline
measure: Acceptability E-scale
timeFrame: 1 month followup
measure: Acceptability E-scale
timeFrame: 3 month followup
measure: Program Evaluation Scale
timeFrame: Baseline
measure: Program Evaluation Scale
timeFrame: 1 month
measure: Program Evaluation Scale
timeFrame: 3 month followup
Secondary outcomes:
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: Baseline
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: 1 month
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: 3 month
measure: Decisional Conflict Scale
timeFrame: Baseline
measure: Decisional Conflict Scale
timeFrame: 1 month
measure: Decisional Conflict Scale
timeFrame: 3 month
measure: Brief Symptom Index (BSI-18)
timeFrame: Baseline
measure: Brief Symptom Index (BSI-18)
timeFrame: 1 month
measure: Brief Symptom Index (BSI-18)
timeFrame: 3 month
measure: Control Preferences Scale (CPS)
timeFrame: Baseline
measure: The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)
timeFrame: Baseline
measure: The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)
timeFrame: 1 month
measure: The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS)
timeFrame: 3 months
measure: Bladder Cancer Knowledge Scale
timeFrame: Baseline
measure: Bladder Cancer Knowledge Scale
timeFrame: 1 month
measure: Bladder Cancer Knowledge Scale
timeFrame: 3 months
measure: Self-Care Difficulty Scale
timeFrame: 1 month
measure: Self-Care Difficulty Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nihal Mohamed, PhD
role: PRINCIPAL_INVESTIGATOR
References: