Exploration of HRQOL and Urinary Outcomes Following Partial Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Self-reported urinary outcomes
研究概览
简要总结
This study explores and compares health-related quality of life and urinary outcomes in postoperative partial cystectomy and matched radical cystectomy patients.
详细描述
PRIMARY OBJECTIVES:
I. Explore and compare urinary outcomes in postoperative partial cystectomy patients and matched radical cystectomy patients through patient-filled questionnaires.
II. Explore and compare health related quality of life in postoperative partial cystectomy and matched radical cystectomy patients using patient-filled questionnaires.
III. Explore the relationship of patient-specific characteristics, ranging from demographic characteristics and clinicopathologic characteristics, on variation in HRQOL and urinary outcomes among the partial cystectomy and radical cystectomy cohorts.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Currently living partial cystectomy patients in Mayo Urology's cystectomy registry and patients undergoing radical or partial cystectomy
- •Matched 2:1 living radical cystectomy to partial cystectomy patients
- •Either urothelial or non-urothelial histology
排除标准
- •Partial cystectomy patients that underwent subsequent radical cystectomy
研究组 & 干预措施
Observational - Radical Cystectomy
Patients complete questionnaires and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
Observational - Partial Cystectomy
Patients complete questionnaires and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Self-reported urinary outcomes
时间窗: Up to 1 year
Assessed using the EORTC Quality of Life Questionnaire - Muscle Invasive Bladder Cancer (EORTC QLQ-BLM30), a 30-item questionnaire related to general symptoms experienced during the past week or during the past 4 weeks. Responses are recorded on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Scores among partial cystectomy patients will be compared to radical cystectomy patients.
Health-related quality of life - EORTC QLQ-C30
时间窗: Up to 1 year
Assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30), which is designed to measure cancer patients' physical, psychological and social functions. It is a 30-item questionnaire related to symptoms and activities during the past week. Responses are recorded on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Scores among partial cystectomy patients will be compared to radical cystectomy patients.
次要结局
未报告次要终点