Digitalization of adverse event management in oncology to improve treatment outcome— a prospective study protocol
peer-reviewed
Erstveröffentlichung
2021-06-04Authors
Kestler, Angelika M. R.
Kühlwein, Silke Daniela
Kraus, Johann Michael
Schwab, Julian
Szekely, Robin
Wissenschaftlicher Artikel
Published in
PLoS ONE ; 16 (2021), 6. - Art.-Nr. e0252493. - eISSN 1932-6203
Link to original publication
https://dx.doi.org/https://doi.org/10.1371/journal. pone.0252493Faculties
Medizinische FakultätInstitutions
UKU. Klinik für Innere Medizin IInstitut für Medizinische Systembiologie
UKU. Comprehensive Cancer Center Ulm (CCCU)
Institut für Geschichte, Theorie und Ethik der Medizin
Document version
published version (publisher's PDF)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.
Subject headings
[GND]: Krebs <Medizin> | Onkologie | Sekundärkrankheit | Arzneimittelnebenwirkung[LCSH]: Cancer; Treatment; Complications
[MeSH]: Neoplasms; Therapy | Neoplasms | Comorbidity | Quality of life
[Free subject headings]: Adverse events | Cell phones | Physicians | Cancer Treatment | Cancers and neoplasms | Adverse reactions | Oncology
[DDC subject group]: DDC 610 / Medicine & health
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Please use this identifier to cite or link to this item: http://dx.doi.org/10.18725/OPARU-38701
Kestler, Angelika M. R. et al. (2021): Digitalization of adverse event management in oncology to improve treatment outcome— a prospective study protocol. Open Access Repositorium der Universität Ulm und Technischen Hochschule Ulm. http://dx.doi.org/10.18725/OPARU-38701
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