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

Abstract

IntroductionWhile 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 analysisA 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 disseminationEthical 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 numberNCT02356081.

Development and preliminary testing of a brief clinical tool to enable daily monitoring of chemotherapy toxicity: The Daily Chemotherapy Toxicity self-Assessment Questionnaire

“…Following development of the DCTAQ, our group carried on to create the e‐DCTAQ, the electronic equivalent of the DCTAQ for use with mobile phones and smartphones (to be reported on a separate publication). Briefly, symptom monitoring via the e‐DCTAQ was coupled with the development of risk algorithms and an alerting system that, whenever a symptom was reported as exceeding a pre‐determined cut‐point, generated and sent alerts to acute care clinicians for action (Maguire et al., ).…”

“…Despite this limitation, we believe that our rigorous investigation of the literature and involvement of cancer care experts in successive review rounds has led to a PRO measure, whose status seems to be in line with medical oncologists’ views and priorities for symptom reporting in clinical practice. Since initial development of the DCTAQ, we have embarked on additional work involving the DCTAQ (Maguire et al., ) and consultation with oncologists from around the world, who have confirmed the content format of the DCTAQ. Moreover, psychometric properties of the DCTAQ were investigated with patients with breast or colorectal cancer; hence, our findings might not apply to groups of patients with other types of cancer.…”

“…Following development of the DCTAQ, our group carried on to create the e-DCTAQ, the electronic equivalent of the DCTAQ for use with mobile phones and smartphones (to be reported on a separate publication). Briefly, symptom monitoring via the e-DCTAQ was coupled with the development of risk algorithms and an alerting system that, whenever a symptom was reported as exceeding a predetermined cut-point, generated and sent alerts to acute care clinicians for action (Maguire et al, 2017). was similar to that of two widely established symptom assessment questionnaires, the Memorial Symptom Assessment Scale (Portenoy et al, 1994) and the Rotterdam Symptom Checklist (de Haes et al, 1996); this might be seen as a point in favour of validity, but definitely cannot be used to draw conclusions on the construct validity of the DCTAQ that will need to be confirmed in the near future.…”

Using Information Technology in the Assessment and Monitoring of Geriatric Oncology Patients

“…Similar to the prior study, the effects of the intervention by age groups were not provided. A larger study is currently ongoing to assess the effects of ASyMS on symptom burden, quality of life, supportive care needs, anxiety, self-care, self-efficacy, work limitations and cost effectiveness [50]. …”

Novel mHealth App to Deliver Geriatric Assessment-Driven Interventions for Older Adults With Cancer: Pilot Feasibility and Usability Study (Preprint)

“…Studies have also shown that mobile health apps can assist with medication management and provide reminders for doctor appointments with resulting improvement in self-care behavior, quality of life, and healthcare utilization [11]. In the cancer setting, mobile health apps have been designed for various uses which include providing education and support, monitoring symptoms and facilitating symptom reporting, monitoring medication adherence, promoting physical activity, and monitoring nutritional status and surgical care [12][13][14][15][16][17][18][19][20]. However, very few mobile apps have been tailored specifically for older adults with cancer who have complex healthcare needs, and/or for their caregivers who themselves frequently have health care issues [21].…”