Bladder CancerNCT00553215
Quality of Life in Patients With Bladder Cancer
An observational study of Bladder Cancer, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- quality-of-life assessment and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 2,700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham
Birmingham, England, B15 2TH
Maurice Zeegers, MD, 44-121-414-6721
About this study
Official title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL]
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- quality-of-life assessment, questionnaire administration
- Keywords
- transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
questionnaire administrationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,700 participants
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Maurice Zeegers, MD, Study chair, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553215
- Sponsor's protocol ID
- CDR0000574081
- Other IDs
- CRUK-BCPP-2005-01-QOL, ISRCTN13889738, EU-20768
- Status last verified
- Feb 2010
- First submitted
- 2 Nov 2007
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [QOL]
- ClinicalTrials.gov ID
- NCT00553215
- Acronym / sponsor ID
- CDR0000574081
- Conditions
- Bladder Cancer
- Keywords
- transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer, stage II bladder cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Dec 2005
- First posted
- 5 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Fit for cystoscopy and surgical biopsy/resection
Key exclusion criteria (6 listed)
- Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis
- 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
- Not specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality-of-life assessment | Procedure or surgery | – |
| questionnaire administration | Procedure or surgery | – |
Primary outcome
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Zeegers, MD study chair
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life as measured by EORTC QLQ-C30, QLQ-BLS24, and QLQ-BLM30 questionnaires. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.