Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders
2014年8月1日 更新者：Zhang Xiaoping、Huazhong University of Science and Technology
A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder
The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy.
The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer.
The findings from this study may help doctors and patients choosing the proper operation type.
研究概览
研究类型
观察性的
注册 (预期的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xiaoping Zhang, MD, PhD
- 电话号码：86 27 85351625
- 邮箱：xzhang@hust.edu.cn
研究联系人备份
- 姓名：Hangchuan Shi, MD
- 电话号码：86 13098893958
- 邮箱：hangchuan_shi@hust.edu.cn
学习地点
-
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Hubei
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Wuhan、Hubei、中国、430022
- 招聘中
- Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
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接触：
- Xiaoping Zhang, MD, PhD
- 电话号码：86 27 85351625
- 邮箱：xzhang@hust.edu.cn
-
接触：
- Hangchuan Shi, MD
- 电话号码：86 13098893958
- 邮箱：hangchuan_shi@hust.edu.cn
-
首席研究员：
- Xiaoping Zhang, MD,PhD
-
首席研究员：
- Hangchuan Shi, MD
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副研究员：
- Xiang Li, MD
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All eligible patients in Wuhan Union Hospital, Huazhong University of Science and Technology.
描述
Inclusion Criteria:
- Clinical diagnosis of muscle invasive bladder cancer
- Must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder
- Must be able to provide informed consent
- Must be 18 years of age or older
- May have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy
Exclusion Criteria:
- Follow-up data not obtained at Wuhan Union Hospital
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
bladder cancer, conduit diversion
new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion
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All eligible patients who agree to participate will be asked to fulfill three different validated health-related quality of life questionnaires (EORTC-QLQ-C30/BLM, FACT-BL and BCI) prior to surgery and at 3, 6, 12, 18 months postoperatively.
|
|
bladder cancer, orthotopic neobladder
new patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder
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All eligible patients who agree to participate will be asked to fulfill three different validated health-related quality of life questionnaires (EORTC-QLQ-C30/BLM, FACT-BL and BCI) prior to surgery and at 3, 6, 12, 18 months postoperatively.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
大体时间：Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL
大体时间：Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
The aim is to compare three various validated tools of HRQoL to study their relative contributions in accounting for variance in prediction of patient HRQoL. The three validated tools of HRQoL are EORTC-QLQ-C30/BLM (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire/bladder cancer module), FACT-BL (Functional Assessment of Cancer Therapy-Bladder cancer) and BCI (Bladder Cancer Index). The two groups are conduit diversion group and orthotopic neobladder group. |
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
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Score changes of each patient group during the follow-up
大体时间：Preoperative baseline and 3, 6, 12, 18 months postoperatively
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Longitudinally learn about the changes of each individual patient HRQoL after urinary diversion and compare the changes of two groups, i.e. conduit diversion group and orthotopic neobladder group.
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Preoperative baseline and 3, 6, 12, 18 months postoperatively
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Objective examination outcomes
大体时间：Preoperative baseline and 3, 6, 12, 18 months postoperatively
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Supplement the assessment by interviewing the patients with some lab and image examinations, such as renal function tests, liver function tests, urine culture, urine cytology, chest radiography, ultrasound of kidney, ureter and bladder (KUB) etc.
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Preoperative baseline and 3, 6, 12, 18 months postoperatively
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Xiaoping Zhang, MD, PhD、Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
- 首席研究员：Hangchuan Shi, MD、Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年8月1日
初级完成 (预期的)
2018年8月1日
研究完成 (预期的)
2018年8月1日
研究注册日期
首次提交
2014年6月22日
首先提交符合 QC 标准的
2014年6月24日
首次发布 (估计)
2014年6月25日
研究记录更新
最后更新发布 (估计)
2014年8月4日
上次提交的符合 QC 标准的更新
2014年8月1日
最后验证
2014年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.