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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05335707

Enrollment

Registered

2022-04-19

Start date

2022-09-14

Completion date

2023-08-21

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Cancer

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results