Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL]
18 Years
N/A
Both
Bladder Cancer
Trial Information
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL]
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires
Principal Investigator
Maurice Zeegers, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Birmingham
Authority:
Unspecified
Study ID:
CDR0000574081
NCT ID:
NCT00553215
Start Date:
December 2005
Completion Date:
Related Keywords:
- Bladder Cancer
- transitional cell carcinoma of the bladder
- stage 0 bladder cancer
- stage I bladder cancer
- stage II bladder cancer
- Urinary Bladder Neoplasms
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