Quality of Life in Patients With Bladder Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00745355

Collaborator

Albert Einstein College of Medicine (Other), Northwell Health (Other), Lenox Hill Hospital (Other), DeltaQuest Foundation, Inc. (Other)

550

Enrollment

Location

168

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Bladder Cancer	Behavioral: Quality Of Life questionnaires

Study Design

Study Type:

Observational

Anticipated 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 :

Aug 1, 2008

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of bladder cancer patients. [conclusion of study]

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. [conclusion of study]
Examine how patients react to more in-depth probing of the interview associated with idiographic assessment. [conclusion of study]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).