Clinical trial · Observational
Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main aim of the study is the evaluation of the feasibility of comprehensive service which has been developed while considering patient-orientated needs. With regard to the study, apps have been developed for both groups of participants, parents and their child which suffers from cancer. These apps aim at supporting the documentation and communication of the own condition. This includes for example a video game which can be played via tablet or smartphone in which questions appear addressing the personally perceived burden by children amongst other things. Participants of the study are children between 6 and 17 years of age which suffer from leukemia or tumors. Further participants of the study are at least one of the patient's parents. It is an observational study. Within the course of the study, the usual treatment is not altered actively by the study, it is, however, supplemented by questionnaires which will be analyzed being anonymized after the end of the study running time.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Childhood | Childhood Leukemia | ONTOLOGY_EXACT | 0.98 |
| Solid Tumor, Childhood | Childhood Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Recruitment rate, defined as percentage of patients eligible for the study from all patients who were screened for the study.
- timeFrame
- Regularly each month in the course of 6-month course of study enrollment.
- description
- This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care and pediatric oncology by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
- measure
- Participation rate, defined as percentage of recruited patients who completed at least 70% of the scheduled questionnaires for 6 months out of all patients eligible for the study
- timeFrame
- Regularly each month in the course of 6-month course of study enrollment
- description
- This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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 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.
References
Publications (2)
- DERIVEDPayne S, Begovic D, Salifu Y, Nelson A, Payne C, Downing J, Natsiavas P, Ling J. Applying Digital Health in Cancer and Palliative Care in Europe: Policy Recommendations from an International Expert Workshop (MyPal Project). J Palliat Med. 2024 Feb;27(2):216-223. doi: 10.1089/jpm.2023.0309. Epub 2023 Sep 22. PMID 37738323
- DERIVEDMeyerheim M, Karamanidou C, Payne S, Garani-Papadatos T, Sander A, Downing J, Stamatopoulos K, Ling J, Payne C, Scarfo L, Lokaj P, Maramis C, Graf N. MyPal-Child study protocol: an observational prospective clinical feasibility study of the MyPal ePRO-based early palliative care digital system in paediatric oncology patients. BMJ Open. 2021 Apr 13;11(4):e045226. doi: 10.1136/bmjopen-2020-045226. PMID 33849855