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

NCT05335707 | Withdrawn

• 1 other identifier: IIT-2021-GerioncBladder
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Test feasibility, acceptability, and preliminary impact

  12 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 and older with biopsy-proven muscle-invasive bladder cancer planned for neoadjuvant chemotherapy and radical cystectomy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: September 14, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 21, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02