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

Withdrawn

• Conditions: Urinary Bladder Cancer

• Registration Number: NCT05335707
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Study Start: 2022-09-14
• Primary Completion: 2023-08-11
• Study Completion: 2023-08-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop a geriatric oncology assessment clinic and workflows	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 Outcome Measures

Name	Time	Method
Test feasibility, acceptability, and preliminary impact	12 months	Test feasibility, acceptability, and preliminary impact of the Comprehensive Geriatric Assessment (CGA) and CGA-directed care.; Note: The results of the CGA will be used by clinicians to guide patients' medical care.