The Personal Patient Profile Decision Support for Patients With Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Behavioral: P3BC
- Registration Number
- NCT05033067
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Patients: cystectomy for MIBC and NMIBC;
- at least 18 years;
- able to communicate in English; and
- competent to give consent.
- Existence of other cancers or ongoing cancer treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention (P3-BC) Usual Care P3BC 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.
- Primary Outcome Measures
Name Time Method Program Evaluation Scale 3 month followup Investigator-designed 12-items instrument to evaluate 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. Full scale ranges from 12-48 with higher scores indicating greater dissatisfaction with the intervention.
Acceptability E-scale 3 month followup Acceptability will be assessed with the six-item Acceptability E-scale. The acceptability is defined as 80% acceptable ratings (using mean score of more than 18 on the scale). Using well-established feasibility criteria to assess: 1) monthly screening rate, 2) monthly enrollment rate, 3) proportion of eligible patients screened who are actually recruited, 4) proportion and demographic and clinical characteristics of patients who decline to participate and reasons for refusal, 5) retention/drop-out rates, and 6) duration and completion rate of study assessments. The AES uses a 5-point response scale for each item (1=not acceptable, 5=highly acceptable). Full score from 0 - 30, with higher score indicating higher overall acceptability
- Secondary Outcome Measures
Name Time Method The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS) 3 months The Cancer Rehabilitation Evaluation System (CARES-MIS) - Medical Interaction Subscale will be used to assess perceived problems with communication with providers.
The CARES - Medical Interaction Subscale includes 11items 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 with higher scores indicating poorer perceived communication.Brief Symptom Index (BSI-18) 3 month Brief Symptom Index (BSI-18) will be used psychological to assess distress. BSI-18 is a self-report 18-item instrument. Raw scores on the BSI-18 are converted to t-scores based on gender-specific normative data from non-patient community dwelling U.S. adults. A T-score = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating more symptom.
Decisional Conflict Scale 3 month 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 - 100 with higher total scores indicating higher decisional conflict.
Bladder Cancer Knowledge Scale 3 months 20 investigator-designed items will evaluate patients' knowledge about bladder cancer.Scores range from 1 (Completely certain that is true) to 5 (Completely certain that is false). Total scale from 20-100, with higher scores indicating less knowledge about bladder cancer.
Control Preferences Scale (CPS) Baseline The Control Preferences Scale (CPS) consists of 5 statements designed to elicit patients' preferences for control over decision making. The CPS involves subjects in making a series of paired comparisons to provide their total preference order over the five statements. Six scores are possible based on the subject's two most preferred roles: active-active, active-collaborative, collaborative-active, collaborative-passive, passive-collaborative, and passive-passive. These scores are grouped as: active (active-active or active-collaborative), collaborative (collaborative-active or collaborative-passive), or passive (passive-collaborative or passive-passive).
Shared Decision Making Questionnaire (SDM-Q-9) 3 month Shared decision making will be assessed by the SDMQ-9, a 9-item instrument with full scale from 0-100, higher score indicates more positive attitude towards SDM.
Self-Care Difficulty Scale 3 months Self-Care Difficulty Scale - Difficulties in self-care will be assessed through 7 investigator-designed items. Scores range from No (0) or Yes (1), with full scale from 0-7. A higher score indicates greater difficulties in self-care.
Trial Locations
- Locations (2)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Washington
🇺🇸Seattle, Washington, United States