Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall survival
时间窗: Up to 1 year after radical cystectomy
Median overall survival (years)
Disease-free survival (DFS)
时间窗: Up to 1 year after radical cystectomy
Median disease-free survival (year)
Treatment Convenience
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点