The eSMART study protocol : a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer

Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. Trial registration number NCT02356081

Adaptation and implementation of a multinational eHealth intervention for people with cancer : reflections from the field

Background: There has been an international shift in healthcare which has seen an increasing focus and development of technological and personalized at-home interventions which aim to improve health outcomes and patient-clinician communication. However, there is a notable lack of empirical evidence describing the preparatory steps of adapting and implementing technology of this kind across multiple countries and clinical settings. Objective: To describe the steps undertaken in the preparation of a multinational, multicentre randomized controlled trial to test a mobile phone-based remote symptom monitoring system, i.e. Advanced Symptom Management System Remote Technology (ASyMS), designed to enhance management of chemotherapy toxicities amongst people with cancer receiving adjuvant chemotherapy versus standard cancer centre care. Methods: Multiple steps were undertaken, including; a scoping review of empirical literature and clinical guidelines, translation and linguistic validation of study materials, development of standardised international care procedures and the integration and evaluation of the technology within each cancer centre. Results: ASyMS was successfully implemented and deployed in clinical practice across five European countries. The rigorous and simultaneous steps undertaken by the research team highlighted the strengths of the system in clinical practice, as well as the clinical and technical changes required to meet the diverse needs of its intended users within each country, prior to the commencement of the randomized controlled trial. Conclusions: Adapting and implementing this multinational, multicentre system required close attention to diverse considerations and unique challenges, primarily related to communication, clinical and technical issues. Success was dependent on collaborative and transparent communication amongst academics, technology industry, translation partners, patients, and clinicians as well as a simultaneous and rigorous methodological approach within the five relevant countries