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

NCT ID: NCT05335707

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2023-08-21

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.

Conditions

Urinary Bladder Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Wulff-Burchfield, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IIT-2021-GerioncBladder

Identifier Type: -

Identifier Source: org_study_id