The main objective is to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in peadiatric oncology by adapting and advancing ePRO systems.

The corresponding primary outcome measures are the rates of recruitment, participation, adherence and premature discontinuation to the different components of the MyPal digital health platform during study enrolment. Further primary outcome measures are quantitative and qualitative data to be collected as follow-up to study enrolment: quantitative data from parents through the standardised System Usability Scale (SUS)11 as well as from the children through a newly adapted version of the SUS; qualitative data through structured interviews and focus groups with participants to identify further barriers, facilitators, preferences and engagement with regards to the MyPal digital health platform as well as differences between the participating clinical sites.

Secondary objectives of this study are to demonstrate the appropriateness and acceptability of several ePRO assessment tools, specifically:

Of children’s symptom burden through a novel digital adaptation of the validated print versions of the Mini-SSPedi and SSPedi questionnaires12 13 as secondary outcome measure during study enrolment.

Of children’s QoL under cancer treatment through the Pediatric Quality of Life Inventory (PedsQL) Cancer Module14 15 as a secondary outcome measure during study enrolment.

Of parents’ burden through the Impact on Family Scale as a secondary outcome measure during study enrolment, specifically with regards to: financial impact, family-social impact and personal strain for the primary family carer.16

Of the QoL of parents having a child with cancer to be assessed through the European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)17 as a secondary outcome measure during study enrolment. The parents’ QoL will be evaluated with regards to the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Of parents’ satisfaction with the care offered to their children with cancer using the European Organisation for Research and Treatment of Cancer satisfaction with cancer care core questionnaire (EORTC PATSAT C33)18 19 as a secondary outcome measure during study enrolment, which assesses patients’ perception of the quality of medical and nursing care, as well as the organisation of care and services of an oncology department. It has been adapted appropriately to assess parents’ satisfaction with children’s cancer care in agreement with the authors of the questionnaire.

Further secondary objectives are:

To determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer. This objective is linked to both the primary outcome measures as well as to EORTC PATSAT C33 as secondary outcome measure.

To determine the impact and effect on healthcare professionals in two European countries due to the integration of ePROs in palliative care. The corresponding secondary outcome measure is a specifically developed web-based online questionnaire to be completed as follow-up to study enrolment, evaluating strain parameters such as additional time spent on care, usability, user-experience.

To contribute to the evidence-base of the effectiveness of ePROs in palliative care and paediatric oncology which is linked to Mini-SSPedi/SSPedi and to the developed web-based online questionnaire as secondary outcome measures.

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