Pediatric Leukemia and solid tumors Z51.5 C95.0 C00-C97
Conditions
Interventions
Group 1: Pediatric-oncological patients will be asked once at the beginning of the study enrollment and in the following on a monthly basis via PedsQL Cancer Module about their quality of life. In add
Sponsors
Centre for Research and Technology Hellas
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for children: • 6-17 years of age • Diagnosed with paediatric leukaemia or solid cancer in the past 12 months • Receiving anti-cancer treatment at one of the participating clinical site • Have age-appropriate speaking, reading and comprehension skills in either the German or the Czech language • Provide signed + informed consent from parents or legal representative and the assent form by all children from the age of 14 years. These documents had been evaluated positively by IEC. • Access to an internet connection and mobile device (e.g. smartphone or tablet) Inclusion criteria for parents: • Parent(s) with a child eligible for the study, as per the inclusion and exclusion-criteria • Ability to speak, read and understand German or Czech language • Provide signed informed consent by parent(s). These documents had been evaluated positively by IEC. • Access to an internet connection and mobile device (e.g. smartphone or tablet)
Exclusion criteria
Exclusion criteria: Exclusion criteria for children • Anyone who is not able to participate in the study according to the clinical judgment of the site chief investigator or any other authorized person of the research team. This judgment has to be documented for each child not being enrolled. Exclusion criteria for parents • Anyone who is not able to participate in the study according to the clinical judgment of the site chief investigator or any other authorized person of the research team. This judgment has to be documented for each parent not being enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care and pediatric oncology by adapting and advancing ePRO systems. Primary Outcome Measures: - Rates of recruitment, participation, adherence and premature discontinuation to the different components of the MyPal digital health platform during study enrolment - Quantitative data through System Usability Scale and an adapted version for children at the end of study enrolment - Qualitative data through structured interviews and focus groups at the end of study enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the appropriateness and acceptability of measures: - of symptom burden for children with cancer through a novel digital adaptation of the validated print versions of the Mini-SSPedi and SSPedi questionnaires as Secondary Outcome Measure during study enrollment - of children’s quality of life under cancer treatment through the PedsQLTM Cancer Module [13, 14] as Secondary Outcome Measure during study enrolment - of parents’ burden through the Impact on Family Scale questionnaire as Secondary Outcome Measure during study enrolment - of the QoL of parents having a child with cancer to be assessed through EQ-5D-3L as Secondary Outcome Measure during study enrolment - of parents’ satisfaction with the care offered to their children with cancer using the EORTC PATSAT C33 as Secondary Outcome Measure during study enrolment To determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer. This 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. To contribute to the evidence-base of the effectiveness of ePROs in palliative care and pediatric oncology which is linked to Mini-SSPedi/SSPedi and to the developed web-based online questionnaire for healthcare professionals as Secondary Outcome Measures. | — |
Countries
Czechia, Germany
Contacts
Public ContactNorbert Graf
Pädiatrische Onkologie und HämatologieUniversitätsklinik des Saarlandes
Outcome results
None listed