A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
- Conditions
- Urinary Bladder Neoplasms
- Registration Number
- NCT05742867
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
-
Must reside in Japan and able to speak/read Japanese for the interview/survey
-
Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):
- ypT2-ypT4a or ypN+ MIBC, with prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
- pT3-pT4a or pN+ MIBC, without prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
-
Must not have received any treatment related to MIBC after radical cystectomy
- Determined by the physician as being unsuitable for the study (e.g. having any clinically significant psychiatric disorder, cognitive impairment, or having difficulty with communicating in Japanese)
- Confirmed diagnosis of other primary cancers at the time of obtaining consent
- Current participation in a MIBC clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival Up to 1 year after radical cystectomy Median overall survival (years)
Disease-free survival (DFS) Up to 1 year after radical cystectomy Median disease-free survival (year)
Treatment Convenience Up to 1 year after radical cystectomy Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks)
Hospitalization Up to 1 year after radical cystectomy Defined as the length of hospitalization required for administration of treatment categorized as 0 days (no hospitalization required for administration of treatment), 1 week, or more than 1 week
5-year survival rate Up to 1 year after radical cystectomy Defined as the percentage of patients that are alive after 5 years
Probability of side effect-related treatment discontinuation Up to 1 year after radical cystectomy Defined as the percent likelihood that a patient will stop treatment due to a side effect
Overall severity of side effects Up to 1 year after radical cystectomy Defined as the severity of side effects categorized as "None", "mild-to-moderate", or "severe"
Number of participants who experience treatment side effects Up to 1 year after radical cystectomy Defined as the percentage of participants who experience nausea, diarrhea, fatigue, skin-related side effects (e.g. pruritus, rash), endocrine system-related side effects (e.g. hypothyroidism), anemia, alopecia, reduced renal function, cardiac impairment, leukopenia, neutropenia, and thrombocytopenia due to treatment
Treatment duration Up to 1 year after radical cystectomy Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year
Frequency of outpatient consultations Up to 1 year after radical cystectomy Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months
Annual treatment costs Up to 1 year after radical cystectomy Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Morrisville, North Carolina, United States