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Quality of Life in Patients With Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
quality-of-life assessment
questionnaire administration
Sponsored by
University of Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Bladder Cancer focused on measuring transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of BirminghamRecruiting

Outcomes

Primary Outcome Measures

Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires

Secondary Outcome Measures

Full Information

First Posted
November 2, 2007
Last Updated
January 9, 2014
Sponsor
University of Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00553215
Brief Title
Quality of Life in Patients With Bladder Cancer
Official Title
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL]
Study Type
Observational

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Birmingham

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer

7. Study Design

Enrollment
2700 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Type
Procedure
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Zeegers, MD
Organizational Affiliation
University of Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurice Zeegers, MD
Phone
44-121-414-6721

12. IPD Sharing Statement

Learn more about this trial

Quality of Life in Patients With Bladder Cancer

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