- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174185
Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders
A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xiaoping Zhang, MD, PhD
- Phone Number: 86 27 85351625
- Email: xzhang@hust.edu.cn
Study Contact Backup
- Name: Hangchuan Shi, MD
- Phone Number: 86 13098893958
- Email: hangchuan_shi@hust.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Recruiting
- Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
-
Contact:
- Xiaoping Zhang, MD, PhD
- Phone Number: 86 27 85351625
- Email: xzhang@hust.edu.cn
-
Contact:
- Hangchuan Shi, MD
- Phone Number: 86 13098893958
- Email: hangchuan_shi@hust.edu.cn
-
Principal Investigator:
- Xiaoping Zhang, MD,PhD
-
Principal Investigator:
- Hangchuan Shi, MD
-
Sub-Investigator:
- Xiang Li, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
bladder cancer, conduit diversion
new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
Time Frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL
Time Frame: 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
|
Score changes of each patient group during the follow-up
Time Frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
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.
|
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Objective examination outcomes
Time Frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
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.
|
Preoperative baseline and 3, 6, 12, 18 months postoperatively
|
Collaborators and Investigators
Investigators
- Study Director: Xiaoping Zhang, MD, PhD, Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
- Principal Investigator: Hangchuan Shi, MD, Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-18-530605
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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