Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29.
研究概览
简要总结
This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies.
详细描述
This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies. Primarily, the study will evaluate health related quality of life and resiliency in patients throughout the perioperative course of a radical cystectomy for bladder cancer.
The primary objective will be the correlation of the Connor-Davidson Resilience Scale (CD-RISC-25) and the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-BL-Cys) score.
Patients will be identified and undergo consent and baseline assessments, including completion of surveys prior to their cystectomy. A retrospective chart review will also be completed to record information regarding patient's cancer stage, treatment status, diagnosis date, insurance type, and related medical conditions and medications. Data from retrospective chart review will be collected and recorded in a secure REDCap database for all eligible patients.
Subsequent surveys will be administered again at approximately 10-30 days postoperatively, as well as 60-120 days postoperatively.
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
- •Patients with a diagnosis of bladder cancer
- •Patients electing to undergo radical cystectomy as treatment
- •≥ 18 years of age
- •Able to speak and read English
- •Willing and able to provide informed consent
- •Functioning telephone number or access to one
排除标准
- •Patients opting to not undergo radical cystectomy
结局指标
主要结局
Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29.
时间窗: Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative
The PROMIS-29 is a disease non-specific measure of pain intensity using a 1-5 rating and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). Scoring: High scores mean more of the concept being measured.
Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25).
时间窗: Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative
The Connor-Davidson Resilience scale is a 25-item self-administered instrument for assessing resilience that is consistent in a variety of populations, including clinical and community. Scoring: 0-100 (sum total of all items, each of which is scored 0-4). Higher score reflects greater resilience.
Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys).
时间窗: Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative
The FACT-BL-Cys is a condition-specific instrument for patients undergoing radical cystectomy to measure quality of life. Scoring: 0-168 (sum total of all items). Higher score reflects better health-related quality of life.
次要结局
- Demographics(Baseline to 90-days (+/-30 days) post-operative)
- Identification of clinical and demographic factors in bladder cancer patients(Baseline to 90-days (+/-30 days) post-operative)
研究者
Eugene Lee, MD
Associate Professor and Urologic Oncology Fellowship Director
University of Kansas Medical Center