Quality of Life in Patients With Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
North Shore Long Island Jewish Health System
Lenox Hill Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00745355
First received: August 22, 2008
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Bladder Cancer
Behavioral: Quality Of Life questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Quality of Life in Patients With Bladder Cancer

Resource links provided by NLM:


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 ]

Estimated Enrollment: 550
Study Start Date: August 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
new patients with 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:   18 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Bernard Bochner, MD    646-422-4387      
Contact: Guido Dalbagni, MD    646-422-4394      
Principal Investigator: Bernard Bochner, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Albert Einstein College of Medicine of Yeshiva University
North Shore Long Island Jewish Health System
Lenox Hill Hospital
Investigators
Principal Investigator: Bernard Bochner, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00745355     History of Changes
Other Study ID Numbers: 08-076
Study First Received: August 22, 2008
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of Life
Questionnaires
08-076

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014