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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02174185
Enrollment
300
Registered
2014-06-25
Start date
2014-08-31
Completion date
2018-08-31
Last updated
2014-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, conduit diversion, orthotopic neobladder, health-related quality of life, validated questionnaire

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.

Interventions

BEHAVIORALvalidated 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.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversionsPreoperative baseline and 3, 6, 12, 18 months postoperatively

Secondary

MeasureTime frameDescription
Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoLPreoperative baseline and 3, 6, 12, 18 months postoperativelyThe 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-upPreoperative baseline and 3, 6, 12, 18 months postoperativelyLongitudinally 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 outcomesPreoperative baseline and 3, 6, 12, 18 months postoperativelySupplement 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.

Countries

China

Contacts

Primary ContactXiaoping Zhang, MD, PhD
xzhang@hust.edu.cn86 27 85351625
Backup ContactHangchuan Shi, MD
hangchuan_shi@hust.edu.cn86 13098893958

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026