This trial is active, not recruiting.

Condition bladder cancer
Treatment quality of life questionnaires
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Albert Einstein College of Medicine of Yeshiva University
Start date August 2008
End date August 2016
Trial size 550 participants
Trial identifier NCT00745355, 08-076


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
new patients with bladder cancer and/or are scheduled for radical cystectomy and urinary diversion
quality of life questionnaires
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.

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

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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.

Additional Information

Official title A Prospective Study of Quality of Life in Patients With Bladder Cancer
Principal investigator Bernard Bochner, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.