A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder

Study Overview
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Brief Summary
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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.

Official Title
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Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan

Conditions
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Urinary Bladder Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Median overall survival (years) | Up to 1 year after radical cystectomy | 
| 5-year survival rate | Defined as the percentage of patients that are alive after 5 years | Up to 1 year after radical cystectomy | 
| Disease-free survival (DFS) | Median disease-free survival (year) | Up to 1 year after radical cystectomy | 
| Probability of side effect-related treatment discontinuation | Defined as the percent likelihood that a patient will stop treatment due to a side effect | Up to 1 year after radical cystectomy | 
| Number of participants who experience treatment side effects | 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 | Up to 1 year after radical cystectomy | 
| Overall severity of side effects | Defined as the severity of side effects categorized as None, mild-to-moderate, or severe | Up to 1 year after radical cystectomy | 
| Treatment Convenience | Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks) | Up to 1 year after radical cystectomy | 
| Treatment duration | Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year | Up to 1 year after radical cystectomy | 
| Hospitalization | 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 | Up to 1 year after radical cystectomy | 
| Frequency of outpatient consultations | Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months | Up to 1 year after radical cystectomy | 
| Annual treatment costs | Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY | Up to 1 year after radical cystectomy |