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

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 rec...

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Autores principales:	Angelika M R Kestler, Silke D Kühlwein, Johann M Kraus, Julian D Schwab, Robin Szekely, Patrick Thiam, Rolf Hühne, Niels Jahn, Axel Fürstberger, Nensi Ikonomi, Julien Balig, Rainer Schuler, Peter Kuhn, Florian Steger, Thomas Seufferlein, Hans A Kestler
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/7c4f2bc7cbab4343b2e462efc97fb19c
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spelling	oai:doaj.org-article:7c4f2bc7cbab4343b2e462efc97fb19c2021-12-02T20:07:19ZDigitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.1932-620310.1371/journal.pone.0252493https://doaj.org/article/7c4f2bc7cbab4343b2e462efc97fb19c2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0252493https://doaj.org/toc/1932-6203The 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.Angelika M R KestlerSilke D KühlweinJohann M KrausJulian D SchwabRobin SzekelyPatrick ThiamRolf HühneNiels JahnAxel FürstbergerNensi IkonomiJulien BaligRainer SchulerPeter KuhnFlorian StegerThomas SeufferleinHans A KestlerPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0252493 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Angelika M R Kestler Silke D Kühlwein Johann M Kraus Julian D Schwab Robin Szekely Patrick Thiam Rolf Hühne Niels Jahn Axel Fürstberger Nensi Ikonomi Julien Balig Rainer Schuler Peter Kuhn Florian Steger Thomas Seufferlein Hans A Kestler Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.
description	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.
format	article
author	Angelika M R Kestler Silke D Kühlwein Johann M Kraus Julian D Schwab Robin Szekely Patrick Thiam Rolf Hühne Niels Jahn Axel Fürstberger Nensi Ikonomi Julien Balig Rainer Schuler Peter Kuhn Florian Steger Thomas Seufferlein Hans A Kestler
author_facet	Angelika M R Kestler Silke D Kühlwein Johann M Kraus Julian D Schwab Robin Szekely Patrick Thiam Rolf Hühne Niels Jahn Axel Fürstberger Nensi Ikonomi Julien Balig Rainer Schuler Peter Kuhn Florian Steger Thomas Seufferlein Hans A Kestler
author_sort	Angelika M R Kestler
title	Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.
title_short	Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.
title_full	Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.
title_fullStr	Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.
title_full_unstemmed	Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.
title_sort	digitalization of adverse event management in oncology to improve treatment outcome-a prospective study protocol.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/7c4f2bc7cbab4343b2e462efc97fb19c
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Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol.

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