Fitness AfteR Oesophagectomy (FARO): study protocol for an external pilot trial of the impact of rehabilitation on quality of life after surgery for oesophageal cancer

Abstract

Introduction Curative treatment of gastro-oesophageal cancer encompasses surgery and peri-operative chemo(radio)therapy. Oesophagectomy carries significant morbidity and mortality with an adverse impact upon patients’ quality of life (QoL). Advancements in oncological treatment and surgical techniques have resulted in incremental prognostic gains with increasing focus on survivorship and optimising QoL. Despite enhanced recovery pathways, patients receive no assistance to improve physical functioning and QoL in the recovery period following hospital discharge. Post-operative rehabilitation has demonstrated improvement in physical fitness and psychosocial wellbeing among other cancer subtypes. There is a need to develop rehabilitative interventions that improve and restore patients’ QoL following an oesophagectomy. The aim of the FARO (Fitness AfteR Oesophagectomy) pilot trial is to determine if a pragmatic, patient-directed rehabilitation programme following oesophagectomy improves patients’ QoL. Methods The FARO study is a prospective, single-centre, parallel group, open-label, two-arm pragmatic randomised controlled external pilot trial that will run over 24 months. The trial aims to recruit 60 patients undergoing oesophageal cancer surgery. Patients will be randomized to receive standard clinical care or post-operative rehabilitation (alongside standard clinical care) in a 1:1 ratio. The rehabilitation intervention encompasses a 12-week home-based programme with weekly step-count targets, completion of resistance exercises and dietary monitoring. The primary outcome is patients’ health-related quality of life (assessed by the EORTC QLQ-C30 and OG-25 questionnaires). Secondary outcomes include cardiopulmonary fitness, functional impact of sarcopenia and biochemical nutritional markers. Outcomes are measured at baseline (at discharge from hospital post-oesophagectomy), 6 weeks, 3- and 6 months post-surgery. Discussion This external pilot trial aims to assess if a patient-directed rehabilitation programme following oesophagectomy restores and improves patients’ HR-QOL and recovery of physical functioning. Further, the trial aims to obtain adequate pilot data to plan a future definitive UK-wide trial of perioperative rehabilitation following oesophagectomy. Trial registration number: ISRCTN Registry ISCRTN73024784; Pre-results