Quality of Life in Patients With Bladder Cancer

University of Birmingham

Status: Unknown

Conditions: Bladder Cancer

Treatments: Procedure: questionnaire administration; Procedure: quality-of-life assessment

Study type: Observational

Funder types: Other

Identifiers

NCT00553215

CRUK-BCPP-2005-01-QOL

EU-20768

ISRCTN13889738

CDR0000574081

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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