Quality of Life in Patients With Bladder Cancer
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Procedure: quality-of-life assessment Procedure: questionnaire administration |
Phase 3 |
| Study Type: | Observational |
| Official Title: | Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL] |
- Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires
| Estimated Enrollment: | 2700 |
| Study Start Date: | December 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| University of Birmingham | Recruiting |
| Birmingham, England, United Kingdom, B15 2TH | |
| Contact: Maurice Zeegers, MD 44-121-414-6721 | |
| Study Chair: | Maurice Zeegers, MD | University of Birmingham |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00553215 History of Changes |
| Other Study ID Numbers: | CDR0000574081, CRUK-BCPP-2005-01-QOL, ISRCTN13889738, EU-20768 |
| Study First Received: | November 2, 2007 |
| Last Updated: | February 25, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
transitional cell carcinoma of the bladder stage 0 bladder cancer stage I bladder cancer stage II bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013