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

August 22, 2008
September 11, 2014
August 2008
August 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00745355 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
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Quality of Life in Patients With Bladder Cancer
A Prospective Study of Quality of Life in Patients With Bladder Cancer

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

All eligible MSKCC patients.

Bladder Cancer
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.
1
new patients with bladder cancer and/or are scheduled for radical cystectomy and urinary diversion
Intervention: Behavioral: Quality Of Life questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
August 2015
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Bernard Bochner, MD 646-422-4387
Contact: Guido Dalbagni, MD 646-422-4394
United States
 
NCT00745355
08-076
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Albert Einstein College of Medicine of Yeshiva University
  • North Shore Long Island Jewish Health System
  • Lenox Hill Hospital
Principal Investigator: Bernard Bochner, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

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