Quality of Life in Patients With Bladder Cancer

This study is currently recruiting participants.

Verified May 2013 by Memorial Sloan-Kettering Cancer Center

Sponsor:

Collaborators:

Albert Einstein College of Medicine of Yeshiva University

North Shore Long Island Jewish Health System

Information provided by (Responsible Party):

Memorial Sloan-Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00745355

First received: August 22, 2008

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2008

Last Updated Date

May 16, 2013

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of bladder cancer patients. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00745355 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Examine how patients react to more in-depth probing of the interview associated with idiographic assessment. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Quality of Life in Patients With Bladder Cancer

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

All eligible MSKCC patients.

Condition ^ICMJE

Bladder Cancer

Intervention ^ICMJE

Behavioral: 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.

Study Group/Cohort (s)

new patients with bladder cancer and/or are scheduled for radical cystectomy and urinary diversion

Intervention: Behavioral: Quality Of Life questionnaires

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

550

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bernard Bochner, MD	646-422-4387
Contact: Guido Dalbagni, MD	646-422-4394

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00745355

Other Study ID Numbers ^ICMJE

08-076

Has Data Monitoring Committee

Not Provided

Responsible Party

Memorial Sloan-Kettering Cancer Center

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Albert Einstein College of Medicine of Yeshiva University
North Shore Long Island Jewish Health System

Investigators ^ICMJE

Principal Investigator:

Bernard Bochner, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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