Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy

N/ACompletedNCT02039310

University of Michigan59 enrolled

Overview

The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bladder Cancer

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic diagnosis of bladder carcinoma (any histology permitted) * Planned treatment with radical cystectomy. * Age 65 years or older at the time of radical cystectomy * Able to give consent * Neoadjuvant chemotherapy is permissible * Prior malignancy is permissible, without evidence of disease for at least 2 years * Concomitant localized prostate cancer, skin cancer, and in situ malignancies are permissible. * Willingness to complete surgical follow-up at the University of Michigan for at least 6 months after radical cystectomy. Exclusion Criteria: * Evidence of metastatic bladder cancer * Life expectancy less than one year * Concurrent treatment on another clinical trial. Non-intervention supportive care trials or non-treatment trials, e.g. QOL, are allowed

Locations (1)

Outcomes

Primary Outcomes

Impairment Free Survival

Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out.

Time frame: 6 months