Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study

Abstract

Introduction: Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system.

Methods and analysis: We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication.

Ethics and dissemination: Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations.

Trial registration number: ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18.

Keywords: adherence; home-based healthcare management; oral anticancer agents; patient empowerment; safety.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1

Screenshot of the diary showing the window that allows patients to register the tablets taken daily.

Figure 2

Screenshot of the diary showing the window that allows patients to register the onset and intensity of therapy-related rash. The app helps patients to determine the toxicity grade by displaying explanatory texts and pictures.

Figure 3

Screenshot of the oncology dashboard via the web browser. Charts show patient health data, for example, weight, symptoms, personal observations and therapy adherence data.