Quality of Life in Patients With Bladder Cancer | NCT00553215

Studies
Quality of Life in Patients With Bladder Cancer

NCT00553215

Sponsor

University of Birmingham

Status

Unknown status

Last Update Posted

Jan 10, 2014Estimated

Enrollment

2,700

Phase

Not provided

Conditions

Bladder Cancer

Interventions

quality-of-life assessment
questionnaire administration

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 2007

First Submission Date that Met QC Criteria

Nov 2, 2007

First Posted Date

Nov 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2014

Last Update Posted Date

Jan 10, 2014Estimated

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

2,700

Measure	Description	Time Frame
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Maurice Zeegers, MD	University of Birmingham	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Birmingham	Recruiting	Birmingham	England	B15 2TH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
CRUK-BCPP-2005-01-QOL
ISRCTN13889738
EU-20768

Name	Type	Description	Arm Group Labels	Other Names
quality-of-life assessment	Procedure
questionnaire administration	Procedure