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Trial Title:
Quality of Life in Patients With Bladder Cancer
NCT ID:
NCT00553215
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer
stage II bladder cancer
Study type:
Observational
Overall status:
Unknown status
Intervention:
Intervention type:
Procedure
Intervention name:
quality-of-life assessment
Intervention type:
Procedure
Intervention name:
questionnaire administration
Summary:
RATIONALE: Studying quality of life in patients with bladder cancer may help determine
the long-term effects of bladder cancer and may help improve the quality of life for
patients in the future.
PURPOSE: This clinical trial is studying quality of life in patients with bladder cancer.
Detailed description:
OBJECTIVES:
- To study the effects of recurrence and progression on health-related quality of life
(HRQL).
- To study the effects of repeat cystoscopy on HRQL.
- To study the patients' assessments of a hypothetical prognostic model and how this
affects their preference for the mode of surveillance.
OUTLINE: This is a multicenter study.
Quality-of-life questionnaires developed by the European Organization for Research and
Treatment for Cancer (EORTC) will be used. The EORTC QLQ-BLS24 with 24 questions specific
to non-muscle-invasive bladder cancer and the EORTC QLQ-BLM30 with 30 questions specific
to muscle-invasive bladder cancer will be combined and used in conjunction with the
general cancer questionnaire QLQ-C30.
Assessments using the QLQ-C30 will be made at baseline in the entire cohort of patients.
Follow-up assessments using the QLQ-C30, QLQ-BLS24, and QLQ-BLM30 167 will be made at
first routine follow-up and annually until the end of study.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Criteria for eligibility:
Criteria:
DISEASE CHARACTERISTICS:
Inclusion criteria:
- Enrolled on parent protocol CRUK-BCPP-2005-01
- Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or
transitional cell carcinoma meeting 1 of the following criteria:
- Non-muscle-invasive tumor
- Muscle-invasive tumor
- Solitary G1 pTa tumor
Exclusion criteria:
- Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within
the 10 years prior to current diagnosis
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Fit for cystoscopy and surgical biopsy/resection
Exclusion criteria:
- HIV infection
- Any condition that, in the opinion of the local investigator, might interfere with
the safety of the patient or evaluation of the study objectives
PRIOR CONCURRENT THERAPY:
- Not specified
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Birmingham
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Maurice Zeegers, MD
Phone:
44-121-414-6721
Start date:
December 2005
Lead sponsor:
Agency:
University of Birmingham
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00553215