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

• Conditions: Bladder Cancer
• Interventions: Behavioral: validated health-related quality of life questionnaires

• Registration Number: NCT02174185
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-22
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Status Verified: 2014-08
• Study Start: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-04
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bladder cancer, conduit diversion	validated health-related quality of life questionnaires	new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion
bladder cancer, orthotopic neobladder	validated health-related quality of life questionnaires	new patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL	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.
Score changes of each patient group during the follow-up	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.
Objective examination outcomes	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.

Trial Locations

Locations (1)

Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China