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

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 Overview

• Status: Completed
• Conditions: Bladder Cancer

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients meeting eligibility criteria will be recruited from genitourinary cancer clinics at the University of Michigan Comprehensive Cancer Center. Patients undergoing initial consultation, active treatment, or surveillance after endoscopic or intravesical therapy will be identified and screened. Interested patients will be counseled by Dr. Lee or her designee, who will review the rationale and benefits of the study, the potential risks and probability of their occurrence, and the procedures to minimize these risks. Patients who wish to enter the study will be asked to sign a consent form that meets the requirements of the University of Michigan IRB. A signed copy of the patient consent will be entered into the medical record.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
≥ 65 years / opts for radical cystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Cheryl T Lee, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): December 31, 2015
• Study Completion (ACTUAL): December 31, 2015

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (ESTIMATE): January 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: HUM00057382