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

Huazhong University of Science and Technology300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Bladder Cancer

Interventions

validated health-related quality of life questionnairesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Urology, Wuhan Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively

Central Contacts

Xiaoping Zhang, MD, PhD

CONTACT

86 27 85351625 xzhang@hust.edu.cn

Hangchuan Shi, MD

CONTACT

86 13098893958 hangchuan_shi@hust.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.