Quality of Life in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553215
• Other study ID #: CDR0000574081
• Secondary ID: CRUK-BCPP-2005-0
• Status: Recruiting
• Phase: Phase 3
• First received: November 2, 2007
• Last updated: January 9, 2014
• Start date: December 2005

Study information

• Verified date: February 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• quality-of-life assessment

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires