Bladder Cancer
Conditions
Keywords
Frailty, Comprehensive Geriatric Assessment
Brief summary
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
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.
Interventions
OTHERPerioperative geriatric assessment and intervention
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.
Sponsors
Aarhus University Hospital
University of Aarhus
Aalborg University Hospital
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, multicenter, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with muscle-invasive bladder cancer and scheduled radical cystectomy. 2. Planned urinary diversion with an ileal conduit 3. Age ≥ 65 years. 4. Patients considered frail by G8 screening tool (total score ≤14).
Exclusion criteria
1. Patients who refuse or are not able to provide informed consent. 2. Patients who do not speak or understand Danish. 3. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive and out of Hospital (DAOH) | Within 90 days after cystectomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive and out of Hospital (DAOH) | Within 30 days after cystectomy | Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery. |
| Complications | Within 30 and 90 days after cystectomy | Number and severity (Clavien-Dindo grad I-V) |
| Length of stay | Within 90 days after surgery | Number of days hospitalized during the index hospitalization |
| Hospital readmissions | Within 30 and 90 days after cystectomy | Number of days admitted to hospital |
| Patient Quality of Life | Within 30 and 90 days postoperatively | Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L) |
| Mortality | Within 30 and 90 days after cystectomy | Number |
| Chair stand test (CST) | 3 weeks postoperatively | Physical function measured by 30-s CST |
Countries
Denmark
Contacts
CONTACTJørgen Bjerggaard Jensen, Prof., DMSc
CONTACTKatharina S Prior, MD, PhD stud
PRINCIPAL_INVESTIGATORJørgen S Bjerggaard Jensen, Prof., DMSc
Aarhus University Hospital and Aarhus University
Outcome results
None listed