Quality of Life in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00745355
• Other study ID #: 08-076
• Status: Active, not recruiting
• Start date: August 2008
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Albert Einstein College of Medicine, DeltaQuest Foundation, Inc., Lahey Hospital & Medical Center, Lenox Hill Hospital, Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of bladder cancer patients.		conclusion of study
Secondary	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.		conclusion of study
Secondary	Examine how patients react to more in-depth probing of the interview associated with idiographic assessment.		conclusion of study
Secondary	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.		conclusion of study

External Links

•   Memorial Sloan-Kettering Cancer Center