Quality of Life in Patients With Invasive Bladder Cancer - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00745355

Purpose

The purpose of this study is to learn about the quality of life of people living with invasive 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 invasive bladder cancer.

Condition	Intervention
Bladder Cancer	Behavioral: Quality Of Life questionnaires

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Prospective Study of Quality of Life in Patients With Invasive Bladder Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 new patients with invasive bladder cancer and/or are scheduled for radical cystectomy and urinary diversion	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.

Groups/Cohorts

Assigned Interventions

1

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

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All eligible MSKCC patients.

Criteria

Inclusion Criteria:

All patients (male and female) who are diagnosed with invasive bladder cancer and/or are scheduled for radical cystectomy and urinary diversion are eligible for participation in the study.
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.
Participants must be diagnosed with invasive bladder cancer and scheduled for radical cystectomy.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745355

Contacts

Contact: Bernard Bochner, MD		bochnerb@mskcc.org
Contact: Bruce Rapkin, PhD		rapkinb@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Bernard Bochner, MD bochnerb@mskcc.org
Contact: Bruce Rapkin, PhD rapkinb@mskcc.org
Principal Investigator: Bernard Bochner, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Bernard Bochner, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Bernard Bochner, MD )
Study ID Numbers:	08-076
Study First Received:	August 22, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00745355 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Quality of Life
Questionnaires

Study placed in the following topic categories:

Urinary Tract Neoplasm
Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms

Quality of Life
Urogenital Neoplasms
Bladder Neoplasm
Urologic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Urologic Diseases
Urinary Bladder Diseases

Urinary Bladder Neoplasms
Urogenital Neoplasms
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009