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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

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