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

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Behavioral: validated health-related quality of life questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 300

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

• China
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients in Wuhan Union Hospital, Huazhong University of Science and Technology.

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bladder cancer, conduit diversion; new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion	Behavioral: validated health-related quality of life questionnaires; 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	Behavioral: validated health-related quality of life questionnaires; 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	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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• 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: August 1, 2014
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: June 22, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Estimate): August 4, 2014
• Last Update Submitted That Met QC Criteria: August 1, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: bladder cancer; health-related quality of life; orthotopic neobladder; conduit diversion; validated questionnaire
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 01-18-530605