eSMART: A European RCT Evaluating Electronic Symptom Management Using the Advanced Symptom Management System (ASyMS) During Adjuvant Chemotherapy

Background: ASyMS is a mobile‐phone based remote‐monitoring and alert system that enables real‐time monitoring of patients' chemotherapy (CT)–related symptoms. Aims: eSMART aims to evaluate the short‐ and long‐term impact of ASyMS, compared with standard care, on patient reported outcomes and the delivery of care. Additionally, eSMART includes economic evaluation and the development of predictive risk models for experiencing CT‐related symptoms to enable personalised and anticipatory care. Methods: Patients newly diagnosed with breast, haematological, or colorectal cancer and scheduled to receive at least 3 cycles of chemotherapy are recruited across 5 countries and 13 clinical sites. A total of 1108 patients will be randomised to either ASyMS or standard care. Patient demographic and clinical data are collected at baseline, and standardised PROMS are completed at baseline, during 6 cycles of chemotherapy and every 3 months for up to 12 months. The primary outcome measure is the Memorial Symptom Assessment Scale. Secondary measures include: Functional Assessment of Cancer Therapy‐General, Supportive Care Needs Survey‐Short Form 34, State‐Trait Anxiety Inventory, Communication and Attitudinal Self‐Efficacy scale for cancer, Work limitations Questionnaire, EuroQol, and Client Services‐Receipt Inventory. Results: RCT data collection started in May 2016, and to date, 537 patients have been recruited. This presentation will provide an overview of the trial aims and design and reflect on study progress and challenges within the United Kingdom and wider European context. Conclusions: Setting up this multicentre study has been challenging, but eSMART is breaking new ground in multinational ehealth research. Patients are willing to accept randomisation into the study, and recruitment is ongoing