Bladder Cancer
Conditions
Keywords
bladder cancer, shared decision making, behavioral intervention, urinary diversion
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.
Interventions
BEHAVIORALP3BC
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.
Sponsors
Icahn School of Medicine at Mount Sinai
University of Washington
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Agree Using the Acceptability Scale | 1 month Follow-up | 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. |
| Number of Participants Who Agree or Disagree With Statements on the Acceptability E-scale | 1 month followup | 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). |
| Percent of Participants Agreeing or Disagreeing With the Decision Using the Program Evaluation Scale | 1 month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making Questionnaire (SDM-Q-9) | 1 month follow-up | 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. |
| Decisional Conflict Scale | 3 months follow-up | 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. |
| Brief Symptom Index (BSI-18) | 1 month follow-up and 3 month follow-up | 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. |
| Decisional Regret Scale | 3 months follow-up | 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. |
| The Cancer Rehabilitation Evaluation System Medical Interaction Subscale (CARES-MIS) | 1 month follow-up | 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 |
| Bladder Cancer Knowledge Scale | 3 months follow-up | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNihal Mohamed, PhD
Icahn School of Medicine at Mount Sinai
Participant flow
Recruitment details
After obtaining IRB approval for the feasibility study, we approached 114 patients for recruitment into The Personal Patient Profile Decision Support for Patients with Bladder Cancer (P3-BC) study. Of these, 24 patients consented to participate. Common reasons for declining included disease and treatment burden, limited time, and lack of confidence in using technology independently.
Pre-assignment details
Among those who consented, 4 participants were lost to follow-up prior to participation, leaving 20 participants (83%) who engaged with the web-based tool's survey. Of these, 5 participants did not complete sufficient baseline survey engagement (i.e., completing the tool's survey that precedes the randomization step) with the tool and were therefore not assigned to a study group. The remaining 15 participants were randomized, with 10 assigned to the intervention group and 5 to the usual care.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 3.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of participants with Chronic Kidney disease | 1 Participants |
| Number of participants with Diabetes | 1 Participants |
| Number of Participants with Heart Disease | 1 Participants |
| Number of Participants with Peripheral Neuropathy | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
None listed