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Clinical Trials/NCT05335707
NCT05335707
Withdrawn
Not Applicable

Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy: A Pilot Trial

University of Kansas Medical Center0 sitesSeptember 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Bladder Cancer
Sponsor
University of Kansas Medical Center
Primary Endpoint
Develop a geriatric oncology assessment clinic and workflows
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

This single arm pilot study will evaluate the feasibility and acceptability for perioperative Comprehensive Geriatric Assessment (CGA) and CGA-directed supportive and restorative care for patients with muscle-invasive bladder cancer who are planned to undergo preoperative chemotherapy.

Registry
clinicaltrials.gov
Start Date
September 14, 2022
End Date
August 21, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Wulff-Burchfield, MD

Assistant Professor

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Males and females age ≥ 65 years
  • Diagnosis/disease status
  • Histologically proven muscle-invasive bladder cancer (MIBC) without metastatic disease.
  • Patients planning to undergo neoadjuvant chemotherapy and radical cystectomy for MIBC.
  • Treatment with investigational systemic therapy is permitted if participants will be receiving chemotherapy as part of their treatment plan

Exclusion Criteria

  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Any other known invasive malignancy within previous 2 years with the following EXCEPT: low grade prostate cancer on active surveillance, chronic lymphocytic leukemia CLL on surveillance / observation, non-melanoma skin cancers

Outcomes

Primary Outcomes

Develop a geriatric oncology assessment clinic and workflows

Time Frame: 12 months

Develop a geriatric oncology assessment clinic and workflows for the University of Kansas Health System, including University of Kansas Cancer Center St. Francis and Great Bend practices.

Secondary Outcomes

  • Test feasibility, acceptability, and preliminary impact(12 months)

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