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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
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.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Washington
Seattle, Washington, United States
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.
Time frame: 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).
Time frame: 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.
Time frame: 1 month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 3 months follow-up
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