Effect of comprehensive geriatric assessment for frail elderly patients operated for colorectal cancer-the colorectal cancer frailty study: study protocol for a randomized, controlled, multicentre trial

Maria Normann, Niklas Ekerstad, Eva Angenete, Mattias Prytz, Maria Normann, Niklas Ekerstad, Eva Angenete, Mattias Prytz

Abstract

Background: Colorectal cancer (CRC) is the third most common cancer worldwide, with a median age of 72-75 years at diagnosis. Curative treatment usually involves surgery; if left untreated, symptoms may require emergency surgery. Therefore, most patients will be accepted for surgery, despite of high age or comorbidity. It is known that elderly patients suffer higher risks after surgery than younger patients, in terms of complications and mortality. Assessing frailty and offering frail elderly patients individualized treatment according to the comprehensive geriatric assessment (CGA) and care concept has been shown to improve the outcome for frail elderly patients in other clinical contexts.

Methods: This randomized controlled multicentre trial aims to investigate if CGA and care prior to curatively intended surgery for CRC in frail elderly patients will improve postoperative outcome. All patients ≥ 70 years with surgically curable CRC will be screened for frailty using the Clinical Frailty Scale (CFS-9). Frail patients will be offered inclusion. Randomization is stratified for colon or rectal cancer. Patients in the intervention group are, in addition to standard protocol, treated according to CGA and care. This consists of individualized assessments and interventions, established by a multiprofessional team. Patients in the control group are treated according to best known practice as stipulated by Swedish colorectal cancer treatment guidelines, within an enhanced recovery after surgery (ERAS) setting. The primary outcome is 90-day mortality. Secondary outcomes are the length of hospital stay and total number of hospital days within 3 months, discharge destination, 30-day readmission, ADL, safe medication assessment, CFS-9 score, complications, Health-Related Quality of Life (HRQoL) at 2-month follow-up in comparison to baseline measurements, health economical calculations including cost-effectiveness analysis based on costs of hospital care and primary care, mortality and HRQoL at baseline, 2- and 12-month follow-up and all-cause 1-year mortality.

Discussion: The trial is the first of its size and extent to investigate intervention with CGA and care prior to surgery for CRC in frail elderly patients. If this addition proves to be favourable, it could have implications on future care of frail elderly patients with CRC.

Trial registration: ClinicalTrials.gov NCT04358328. Registered on 4 February 2020.

Keywords: CGA and care; Colorectal neoplasm; ERAS; Elderly; Frailty; PICO (patient-intervention-comparison-outcome); RCT (randomised controlled trial); Surgery.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Description of the CGA and care concept in the study
Fig. 2
Fig. 2
Flowchart of the patient flow through the trial. Displaying the differences between control and intervention groups and the screening instrument used at different measuring points

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