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

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.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Patient-specific study enrolment schema of MyPal4Kids. ePROS, electronic patient-reported outcomes.

Figure 2

Software and hardware modules of the MyPal digital health platform. The MyPal Child and carer APP are useable via various types of mobile devices. The user of the MyPal carer APP are the parents/legal guardians involved in the study. Healthcare professionals can use the MyPal carer APP as well to report as proxy for the child.

Figure 3

(A) A screenshot of the gamified symptom questionnaire as part of the MyPal Child app. (B) Screenshots taken of the MyPal carer APP depicting the PATSAT C-33 questionnaire with instruction screen, selection of patient setting screen and one sample question screen.

Figure 4

Symptoms reported by study participants can be visualised in the MyPal web-based app for HCPs to be reviewed according to adjustable settings.