Quality of Life in Patients With Bladder Cancer

NCT ID: NCT00553215

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Interventions

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quality-of-life assessment

Intervention Type PROCEDURE

questionnaire administration

Intervention Type PROCEDURE

Eligibility Criteria

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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


* Fit for cystoscopy and surgical biopsy/resection

Exclusion Criteria

* Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis

PATIENT CHARACTERISTICS:


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Birmingham

OTHER

Sponsor Role lead

Principal Investigators

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Maurice Zeegers, MD

Role: STUDY_CHAIR

University of Birmingham

Locations

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University of Birmingham

Birmingham, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Maurice Zeegers, MD

Role: primary

44-121-414-6721

Other Identifiers

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CRUK-BCPP-2005-01-QOL

Identifier Type: -

Identifier Source: secondary_id

ISRCTN13889738

Identifier Type: -

Identifier Source: secondary_id

EU-20768

Identifier Type: -

Identifier Source: secondary_id

CDR0000574081

Identifier Type: -

Identifier Source: org_study_id

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