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

BMJ Open. 2017 May 29;7(5):e014617. doi: 10.1136/bmjopen-2016-014617.

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.

Publication types

  • Multicenter Study
  • Validation Study

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use
  • Disease Management*
  • Feasibility Studies
  • Female
  • Health Literacy
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Monitoring, Physiologic / methods*
  • Neoplasms / drug therapy
  • Patient Participation*
  • Physician-Patient Relations
  • Research Design
  • Self Administration
  • Telemedicine / standards*
  • Young Adult

Substances

  • Antineoplastic Agents

Associated data

  • ClinicalTrials.gov/NCT02921724