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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
Odense University Hospital
Odense, Denmark
RECRUITINGDays 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.
Time frame: Within 90 days after cystectomy
Days Alive and out of Hospital (DAOH)
Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.
Time frame: Within 30 days after cystectomy
Complications
Number and severity (Clavien-Dindo grad I-V)
Time frame: Within 30 and 90 days after cystectomy
Length of stay
Number of days hospitalized during the index hospitalization
Time frame: Within 90 days after surgery
Hospital readmissions
Number of days admitted to hospital
Time frame: Within 30 and 90 days after cystectomy
Patient Quality of Life
Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)
Time frame: 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)).
Time frame: Within 30 and 90 days postoperatively
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Mortality
Number
Time frame: Within 30 and 90 days after cystectomy
Chair stand test (CST)
Physical function measured by 30-s CST
Time frame: 3 weeks postoperatively