MyPal-Child study protocol: an observational prospective
clinical feasibility study of the MyPal ePRO-based early
palliative care digital system in paediatric oncology patients Journal Article
@article{Meyerheim2021-nz,
title = {MyPal-Child study protocol: an observational prospective
clinical feasibility study of the MyPal ePRO-based early
palliative care digital system in paediatric oncology patients},
author = {Marcel Meyerheim and Christina Karamanidou and Sheila Payne and Tina Garani-Papadatos and Annette Sander and Julia Downing and Kostas Stamatopoulos and J Ling and Cathy Payne and Lydia Scarf`o and Petr Lokaj and Christos Maramis and Norbert Graf},
year = {2021},
date = {2021-04-01},
journal = {BMJ Open},
volume = {11},
number = {4},
pages = {e045226},
abstract = {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.},
keywords = {health informatics; paediatric oncology; paediatric palliative care},
pubstate = {published},
tppubtype = {article}
}
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.