MyPal-Child study protocol: an observational prospective clinical feasibility study of the MyPal ePRO-based early palliative care digital system in paediatric oncology patients

Abstract

IntroductionElectronic 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 analysisIn 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 disseminationThe 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 numbersU1111-1251-0043, DRKS00021458, NCT04381221.

AquaScouts: ePROs Implemented as a Serious Game for Children With Cancer to Support Palliative Care

“…More specifically, Mini-SSPedi ( 12 ) and SSPedi ( 13 ) questionnaires were digitally adapted to collect symptom information, PedSQL ( 14 ) to report QoL impact of the patient, European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) ( 15 ) to report the QoL impact of the parents, and the European Organization for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT C33) ( 16 ) to evaluate the satisfaction of the parents with the treatment of their child and the Impact of Family Scale ( 17 ). These questionnaires are asked as a part of the game or via the “MyPal Carer App” along the specific clinical study protocol and the main research endpoints, which are published by ( 18 ). It should be highlighted that MyPal Carer App is a simple questionnaire answering mobile app being used by the parent (acting as a proxy) only when the patient cannot report him/herself.…”

Advancing Global Palliative Care Over Two Decades: Health System Integration, Access to Essential Medicines, and Pediatrics

“…(60,61) A range of models of pediatric palliative care delivery developed globally, as well as mobile-phone health innovations such as the ICPCN Pain App and the MyPal game for reporting patient outcomes. (62) Research on pediatric palliative care grew rapidly with a PubMed search for papers on children's palliative care showing a 700% increase in publications in 2020 as compared to 2000.…”

Challenges and Pitfalls for Implementing Digital Health Solutions in Clinical Studies in Europe

“…The pediatric oncology departments of the University of Saarland as the coordinating center and Hannover Medical School in Germany as well as the University Hospital Brno in the Czech Republic run MyPal4Kids ( 22 ).…”

“…In this policy brief, we portray experiences and observations made in the course of setting up the currently running observational prospective clinical feasibility MyPal-Child study (MyPal4Kids) ( 22 ). Firstly, we provide an overview on the study and its context.…”