This clinical trial evaluates whether a comprehensive geriatric assessment program for older patients undergoing surgery to remove all of the bladder (radical cystectomy) for bladder cancer can be used and whether it works in improving complications after surgery (post-operative). Standard of care for certain types of bladder cancer can include radical cystectomy. Often times, bladder cancer affects older adults. Radical cystectomy can lead to post-operative complications, hospital readmission, or death. These complications can be more common among older adults due to things like weakness or confusion. The comprehensive geriatric assessment program includes the use of an education program and supportive care peri-operatively. The 4M education program includes information regarding mobility, mentation, medication, and what matters most. The information is provided to patients and their care partners prior to their scheduled radical cystectomy. Supportive care peri-operatively is used to help lower complications, watch for signs of weakness or confusion, and reinforce education points. Using a comprehensive geriatric assessment program may improve post-operative complications among older patients undergoing radical cystectomy for bladder cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06427824.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer CenterStatus: Active
Contact: Piyush K. Agarwal
Phone: 773-702-3080
PRIMARY OBJECTIVES:
I. Assess the feasibility of implementing a low-cost, scalable, pre-operative education program aligning with the Institute for Healthcare Improvement (IHI) and Geriatric Surgery Verification (GSV) program recommendations in radical cystectomy patients ≥ 65 and their care partners.
II. Quantify the acceptability and adoptability of the recommendations.
III. Randomize patients to pre-operative geriatric assessment and additional peri-operative geriatric co-management with the inpatient consultation service, and assess incremental benefit.
IV. Determine whether feasibility, acceptability and adoptability varies by preoperative frailty status measured 4-16 weeks prior to surgery feasibility.
SECONDARY OBJECTIVE:
I. Estimate the impact of the combined 1) preoperative educational intervention, 2) peri-operative frailty orderset, 3) geriatric inpatient consultation (in those patients randomized to this group), and 4) nursing delirium and frailty training on cystectomy surgical outcomes in a pilot sample.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients and their care partners attend an education session that includes 4 learning modules on pre-, peri- and post-operative strategies to reduce mobility loss, optimize medication management, prevent delirium, and document what matters most over 20 minutes up to 16 weeks prior to scheduled radical cystectomy and receive a summary handout of the education session. Patients meeting prefrail or frailty criteria receive a frailty order set after surgery.
GROUP II: Patients and their care partners attend an education session that includes 4 learning modules on pre-, peri- and post-operative strategies to reduce mobility loss, optimize medication management, prevent delirium, and document what matters most over 20 minutes up to 16 weeks prior to scheduled radical cystectomy and receive a summary handout of the education session. Patients also receive peri-operative inpatient co-management with the geriatric service and evaluation by the inpatient team to reinforce the education session learning modules and help with discharge planning during hospitalization. Patients meeting prefrail or frailty criteria receive a frailty order set after surgery.
After completion of study intervention, patients are followed up at 30 and 90 days post-operatively.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorPiyush K. Agarwal
