NCT00745355

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2008Aug 2026

Study Start

First participant enrolled

August 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
17.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

18 years

First QC Date

August 22, 2008

Last Update Submit

May 28, 2025

Conditions

Keywords

Quality of LifeQuestionnaires08-076

Outcome Measures

Primary Outcomes (1)

  • Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of bladder cancer patients.

    conclusion of study

Secondary Outcomes (3)

  • 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

Study Arms (1)

1

new patients with bladder cancer and/or are scheduled for radical cystectomy and urinary diversion

Behavioral: Quality Of Life questionnaires

Interventions

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible MSKCC patients.

You may qualify if:

  • 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).

You may not qualify if:

  • Subjects may be excluded from the study based on the following criteria:
  • Follow-up care not obtained at MSKCC.
  • Metastatic disease at diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Bernard Bochner, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2008

First Posted

September 3, 2008

Study Start

August 1, 2008

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations