A Prospective Study of Quality of Life in Patients With Bladder Cancer

Memorial Sloan Kettering Cancer Center1 site in 1 country550 target enrollmentAugust 2008

ConditionsBladder Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 550
Locations: 1
Primary Endpoint: Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of bladder cancer patients.
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to learn about the quality of life of people living with bladder cancer. We are interested in learning about how the treatments for bladder cancer affect people. We plan to use the findings from this study to help doctors provide better care and information to patients with bladder cancer.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

August 2026

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of bladder cancer patients.

Time Frame: conclusion of study

Secondary Outcomes

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.(conclusion of study)
Examine how patients react to more in-depth probing of the interview associated with idiographic assessment.(conclusion of study)
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.(conclusion of study)