Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder

Conditions
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Bladder Cancer

Intervention / Treatment
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* Behavioral: validated health-related quality of life questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bladder cancer, conduit diversion<br>new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion | Behavioral: validated health-related quality of life questionnaires<br>* 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.<br>|
| bladder cancer, orthotopic neobladder<br>new patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder | Behavioral: validated health-related quality of life questionnaires<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions |  | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, conduit diversion, orthotopic neobladder, health-related quality of life, validated questionnaire