Quality of Life in Patients With Bladder Cancer
Conditions
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
Study Phase
Phase 3
Study Design
N/A
Intervention
Name: quality-of-life assessment Type: Procedure
Name: questionnaire administration Type: Procedure
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
University of Birmingham
Birmingham, England, United Kingdom
Status: Recruiting
Contact: Maurice Zeegers, MD - 44-121-414-6721
Start Date
December 2005
Sponsors
University of Birmingham
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page