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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02174185
• Other study ID #: 01-18-530605
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2014
• Last updated: August 1, 2014
• Start date: August 2014
• Est. completion date: August 2018

Study information

• Verified date: August 2014
• Source: Huazhong University of Science and Technology
• Contact: Xiaoping Zhang, MD, PhD
• Phone: 86 27 85351625
• Email: xzhang[@]hust.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions		Preoperative baseline and 3, 6, 12, 18 months postoperatively	No
Secondary	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	No
Secondary	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	No
Secondary	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	No