Digitalization of adverse event management in oncology to improve treatment outcome��� a prospective study protocol

Autor: Kestler, Angelika M. R., Kühlwein, Silke Daniela, Kraus, Johann Michael, Schwab, Julian, Szekely, Robin, Thiam, Patrick, Hühne, Rolf, Jahn, Niels, Fürstberger, Axel, Ikonomi, Nensi, Balig, Julien, Schuler, Rainer, Kuhn, Peter, Steger, Florian, Seufferlein, Thomas, Kestler, Hans A.
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Male
Health Care Providers
Cancer Treatment
Comorbidity
Neoplasms
Medicine and Health Sciences
Medical Personnel
Cancers and neoplasms
Krebs
Software Engineering
Onkologie
Sekundärkrankheit
Middle Aged
Telemedicine
Cancer
Treatment
Complications
Professions
Oncology
Research Design
Medicine
Engineering and Technology
Female
Immunotherapy
Smartphone
Adverse reactions
Quality of life
Computer and Information Sciences
Clinical Research Design
Science
Immunology
Cell phones
Equipment
Antineoplastic Agents
Research and Analysis Methods
Cancer Immunotherapy
Computer Software
Registered Report Protocol
Physicians
Humans
ddc:610
Arzneimittelnebenwirkung
Aged
Communication Equipment
Pharmacology
Krebs
Therapy
Biology and Life Sciences
Apps
Health Care
Adverse events
People and Places
Sekund��rkrankheit
Population Groupings
Clinical Immunology
Self Report
Clinical Medicine
DDC 610 / Medicine & health
Zdroj: PLoS ONE
PLoS ONE, Vol 16, Iss 6, p e0252493 (2021)
DOI: 10.18725/oparu-38701
Popis: 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 (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.
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Databáze: OpenAIRE
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