MyPal-Child study protocol: an observational prospective clinical feasibility study of the MyPal ePRO-based early palliative care digital system in paediatric oncology patients
Language English Country Great Britain, England Media electronic
Document type Journal Article, Observational Study, Research Support, Non-U.S. Gov't
PubMed
33849855
PubMed Central
PMC8051393
DOI
10.1136/bmjopen-2020-045226
PII: bmjopen-2020-045226
Knihovny.cz E-resources
- Keywords
- health informatics, paediatric oncology, paediatric palliative care,
- MeSH
- Child MeSH
- Quality of Life MeSH
- Humans MeSH
- Adolescent MeSH
- Neoplasms * therapy MeSH
- Palliative Care * MeSH
- Prospective Studies MeSH
- Feasibility Studies MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Adolescent MeSH
- Publication type
- Journal Article MeSH
- Observational Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Czech Republic MeSH
- Europe MeSH
- Germany MeSH
INTRODUCTION: Electronic patient-reported outcomes (ePROs) have tremendous potential to optimise palliative and supportive care for children with cancer, their families and healthcare providers. Particularly, these children and their families are subjected to multiple strains caused by the disease and its treatment. The MyPal digital health platform is designed to address these complex demands by offering pursuant ePRO-based functionalities via two mobile applications, one developed for children and the other for their parents. METHODS AND ANALYSIS: In this observational prospective feasibility study, 100 paediatric oncology patients aged between 6 and 17 years and at least one of their parents/legal guardians will be recruited at three clinical sites in two European countries (Germany and Czech Republic). They will use the mobile applications which are part of the novel digital health platform. During a 6-month study period, participants will complete various ePROs via the applications addressing quality of life, satisfaction with care and impact of the disease on the family at monthly intervals. Additionally, priority-based symptom reporting is integrated into a serious game for children. Outcomes that will be assessed concern the feasibility and the evaluation of the newly designed digital health platform to contribute to the evidence base of clinical ePRO use in paediatric oncology and palliative care process. ETHICS AND DISSEMINATION: The MyPal-Child study obtained ethical approval from the Ethics Committee responsible for the University of Saarland, that is, the Ärztekammer des Saarlandes, the Ethics Committee of the Medical School Hannover and the Ethics Committee of the University of Brno. Study results will be disseminated through scientific publications, presentations at international conferences, congresses and a final report to the European Commission. General publicly accessible information can be found on the project website (www.mypal-project.eu) and social media. TRIAL REGISTRATION NUMBERS: U1111-1251-0043, DRKS00021458, NCT04381221.
Department of Pediatric Oncology University Hospital Brno Brno Jihomoravský Czech Republic
Department of Public Health Policy University of West Attica Athens Attica Greece
Head Office European Association for Palliative Care Vilvoorde Belgium
International Children's Palliative Care Network Bristol Avon UK
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