Impact of feedback from Real-time, electronic symptom monitoring on post-discharge recOvery after Surgery for oEsophago-gastric cancer: a multi-centre randomised controlled trial (the ROSE study)

Aim To find out if patients recovering at home from surgery for oesophago-gastric (food pipe or stomach) cancer benefit from feedback from electronic (web-based) reporting and monitoring of their symptoms. Background Around 13,500 people in England and Wales are diagnosed with oesophago-gastric cancer each year, of which around 5,000 (40%) have major surgery. Patients stay in hospital for around 1-2 weeks after surgery. Even when well enough to continue their recovery at home, patients may still experience surgery-related problems or feel unwell with symptoms such as pain or tiredness. There is growing evidence from patients undergoing other treatments (such as chemotherapy) that electronic (web-based) reporting of symptoms can improve patients wellbeing because it provides a way to provide patients and their healthcare team with feedback about how best to manage symptoms. However, this has not been studied in patients undergoing surgery for cancer. Design and methods We will invite 206 patients having surgery for oesophago-gastric cancer at six NHS hospitals in England to take part. Patients will be randomly placed in one of two groups. Patients in the web-based monitoring and feedback group will be asked to report their symptoms using the web-based system while continuing to receive their usual clinical care. Depending on the seriousness of reported symptoms, the system will immediately provide feedback about self-care, advise them to contact their healthcare team, or send an automatic alert to their healthcare team. Patients in the usual care group will receive their usual clinical care but will not use the web-based system to report symptoms or receive feedback. Patients will complete questionnaires during the study, including before their surgery, when ready for discharge home and at several timepoints up to four weeks after going home from hospital. We will use the questionnaire answers to see if patients in the web-based monitoring and feedback group have a better recovery from their surgery than those in the usual care group. We will also look at whether the web-based system is good value for money for the NHS. Patient and public involvement We have worked closely with patients and members of the public to develop the study and draft this application, including choosing the questionnaires and deciding how many times patients will complete them. We will continue to work with patients and members of the public during the study, for example asking them what information should be included on participant study information leaflets. Communicating study findings We will share our study findings with the NHS and by publishing in scientific journals and presenting at scientific meetings. We will work with patient groups and professional organisations to make sure our findings are shared widely and explained in ways that everyone can understand.