Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol

PLoS One. 2021 Jun 4;16(6):e0252493. doi: 10.1371/journal.pone.0252493. eCollection 2021.

Abstract

The occurrence of adverse events frequently accompanies tumor treatments. Side effects should be detected and treated as soon as possible to maintain the best possible treatment outcome. Besides the standard reporting system Common Terminology Criteria for Adverse Events (CTCAE), physicians have recognized the potential of patient-reporting systems. These are based on a more subjective description of current patient reporting symptoms. Patient-reported symptoms are essential to define the impact of a given treatment on the quality of life and the patient's wellbeing. They also act against an underreporting of side effects which are paramount to define the actual value of a treatment for the individual patient. Here, we present a study protocol for a clinical trial that assesses the potential of a smartphone application for CTCAE conform symptom reporting and tracking that is adjusted to the standard clinical reporting system rather than symptom oriented descriptive trial tools. The presented study will be implemented in two parts, both lasting over six months. The first part will assess the feasibility of the application with 30 patients non-randomly divided into three equally-sized age groups (<55years, 55-75years, >75years). In the second part 36 other patients will be randomly assigned to two groups, one reporting using the smartphone and one not. This prospective second part will compare the impact of smartphone reported adverse events regarding applied therapy doses and quality of life to those of patients receiving standard care. We aim for early detection and treatment of adverse events in oncological treatment to improve patients' safety and outcomes. For this purpose, we will capture frequent adverse events of chemotherapies, immunotherapies, or other targeted therapies with our smartphone application. The presented trial is registered at the U.S. National Library of Medicine ClinicalTrials.gov (NCT04493450) on July 30, 2020.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Female
  • Humans
  • Immunotherapy / adverse effects*
  • Male
  • Middle Aged
  • Neoplasms / drug therapy
  • Neoplasms / therapy*
  • Quality of Life
  • Self Report
  • Smartphone*
  • Telemedicine / instrumentation
  • Telemedicine / methods*

Substances

  • Antineoplastic Agents

Associated data

  • ClinicalTrials.gov/NCT04493450

Grants and funding

The funding to establish the smartphone and desktop application was provided by the Ministry of Science and Art Baden-Württemberg (Zentrum für Innovative Versorgung, ZIV), the German Federal Ministry of Education and Research (BMBF) as part of the DIFUTURE project (Medical Informatics Initiative, grant number 01ZZ1804I), and the Ministry of Social Affairs and Integration Baden-Württemberg as part of the project feelBack (networked, digital, patient-related feedback psycho-oncology). However, the conduction of the here described study receives no funding.