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Quality of Life in Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00745355
Recruitment Status : Active, not recruiting
First Posted : September 3, 2008
Last Update Posted : September 6, 2017
Sponsor:
Collaborators:
Albert Einstein College of Medicine, Inc.
Northwell Health
Lenox Hill Hospital
DeltaQuest Foundation, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Bladder Cancer Behavioral: Quality Of Life questionnaires

Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Quality of Life in Patients With Bladder Cancer
Study Start Date : August 2008
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Examine how patients react to more in-depth probing of the interview associated with idiographic assessment. [ Time Frame: conclusion of study ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745355


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Albert Einstein College of Medicine, Inc.
Northwell Health
Lenox Hill Hospital
DeltaQuest Foundation, Inc.
Investigators
Principal Investigator: Bernard Bochner, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00745355     History of Changes
Other Study ID Numbers: 08-076
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

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