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- Withdrawn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