Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

Study Overview
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Brief Summary
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Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.

Detailed Description
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Patients will be randomized 1:1 and allocated into either control or intervention study arm. The control group will receive perioperative care as usual according to exciting principles and guidelines. The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.

Official Title
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Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: Perioperative geriatric assessment and intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with muscle-invasive bladder cancer and scheduled radical cystectomy. Planned urinary diversion with an ileal conduit Age ≥ 65 years. Patients considered frail by G8 screening tool (total score ≤14). Exclusion Criteria: Patients who refuse or are not able to provide informed consent. Patients who do not speak or understand Danish. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, multicenter, randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional<br>Perioperative care as usual according to exciting principles and guidelines | |
| Experimental: Geriatric<br>Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy. | Other: Perioperative geriatric assessment and intervention<br>* The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment (CGA) and tailored interventions, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days Alive and out of Hospital (DAOH) | Primary outcome will be DAOH counted from day of surgery until 90 days after surgery. DAOH as an endpoint combines the duration of hospital stay, the burden of subsequently readmissions and mortality, and hence is an expression for the expected reduction in medical postoperative complications. | Within 90 days after cystectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days Alive and out of Hospital (DAOH) | Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery. | Within 30 days after cystectomy | 
| Complications | Number and severity (Clavien-Dindo grad I-V) | Within 30 and 90 days after cystectomy | 
| Length of stay | Number of days hospitalized during the index hospitalization | Within 90 days after surgery | 
| Hospital readmissions | Number of days admitted to hospital | Within 30 and 90 days after cystectomy | 
| Patient Quality of Life | Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L) | Within 30 and 90 days postoperatively | 
| Patient Quality of Life | Quality of Life evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30/BLM30 (muscle invasive bladder cancer)). | Within 30 and 90 days postoperatively | 
| Mortality | Number | Within 30 and 90 days after cystectomy | 
| Chair stand test (CST) | Physical function measured by 30-s CST | 3 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Comprehensive Geriatric Assessment