Quality of Life in Patients With Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553215
First received: November 2, 2007
Last updated: January 9, 2014
Last verified: February 2010
  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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires

Estimated Enrollment: 2700
Study Start Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553215

Locations
United Kingdom
University of Birmingham Recruiting
Birmingham, England, United Kingdom, B15 2TH
Contact: Maurice Zeegers, MD    44-121-414-6721      
Sponsors and Collaborators
University of Birmingham
Investigators
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: January 9, 2014
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 September 22, 2014