Quality of Life in Patients With Bladder Cancer
A Prospective Study of Quality of Life in Patients With Bladder Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
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-
New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients (male and female) who are diagnosed with bladder cancer
- Patients must be scheduled for radical cystectomy and urinary diversion are and/or being evaluated for neo-adjuvant chemotherapy prior to a planned cystectomy.
- Participants must be able to speak English.
- Participants must be able to provide informed consent.
- Participants must be 18 years of age or older to enroll.
- Participant may be eligible for and may receive neoadjuvant or adjuvant chemotherapy.
- Participant may have had intravesicle chemotherapy or immunotherapy (BCG, Interferon).
Exclusion Criteria:
- Subjects may be excluded from the study based on the following criteria:
- Follow-up care not obtained at MSKCC.
- Metastatic disease at diagnosis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
1
new patients with bladder cancer and/or are scheduled for radical cystectomy and urinary diversion
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All patients who agree to participate will be interviewed using a baseline idiographic quality of life assessment prior to surgery and at approximately 6, 12, 18 and 24 months postoperatively.
All patients will also be asked to respond to a questionnaire including all standard measures (closed-ended, multiple choice items) before surgery and at approximately 3, 6, 12, 18 and 24 months post-surgery.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of bladder cancer patients.
Time Frame: conclusion of study
|
conclusion of study
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compare various standard and idiographic measures of QOL, to determine their relative contributions in accounting for variance in key outcome criteria and prediction of patient QOL at subsequent assessment points.
Time Frame: conclusion of study
|
conclusion of study
|
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Examine how patients react to more in-depth probing of the interview associated with idiographic assessment.
Time Frame: conclusion of study
|
conclusion of study
|
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Develop a predictive model of QOL after radical cystectomy & urinary diversion using the data from idiographic and standard QOL measures. This model can ultimately be used in office based practice to guide treatment planning with each patient.
Time Frame: conclusion of study
|
conclusion of study
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Bernard Bochner, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 08-076
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