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

Urinary Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05335707
• Other study ID #: IIT-2021-GerioncBladder
• Status: Withdrawn
• Start date: September 14, 2022
• Est. completion date: August 21, 2023

Study information

• Verified date: February 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 21, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop a geriatric oncology assessment clinic and workflows	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.	12 months
Secondary	Test feasibility, acceptability, and preliminary impact	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.	12 months