Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol.

INTRODUCTION

Technology is emerging as a solution to develop home-based, proactive 'real-time' symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.

METHODS AND ANALYSIS

This study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS-Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians.

ETHICS AND DISSEMINATION

The study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT03335189.