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

Tools

Moradian, Saeed and Krzyzanowska, Monika and Maguire, Roma and Kukreti, Vishal and Amir, Eitan and Morita, Plinio P and Liu, Geoffrey and Liu, Geoffrey and Howell, Doris (2020) Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can) : a study protocol. BMJ Open, 10. e035648. ISSN 2044-6055 (https://doi.org/10.1136/bmjopen-2019-035648)

[thumbnail of Moradian-etal-BMJOpen-2020-Feasibility-randomised-controlled-trial-of-remote-symptom-chemotherapy-toxicity-monitoring]
Preview
 Text. Filename: Moradian_etal_BMJOpen_2020_Feasibility_randomised_controlled_trial_of_remote_symptom_chemotherapy_toxicity_monitoring.pdf
Final Published Version
License: Creative Commons Attribution-NonCommercial 4.0 logo
Download (959kB)| Preview

Abstract

Introduction Technology is emerging as a solution to develop home-based, proactive â € 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.

ORCID iDs

Moradian, Saeed, Krzyzanowska, Monika, Maguire, Roma ORCID logoORCID: https://orcid.org/0000-0001-7935-3447, Kukreti, Vishal, Amir, Eitan, Morita, Plinio P, Liu, Geoffrey, Liu, Geoffrey and Howell, Doris;
CORE (COnnecting REpositories)