Urinary Bladder Neoplasms
Conditions
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.
Interventions
None listed
Sponsors
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| Overall survival | Up to 1 year after radical cystectomy | Median overall survival (years) |
| 5-year survival rate | Up to 1 year after radical cystectomy | Defined as the percentage of patients that are alive after 5 years |
| Disease-free survival (DFS) | Up to 1 year after radical cystectomy | Median disease-free survival (year) |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed