Neoplasms

Blood and Lymph Conditions

All Conditions

Leukemia

Norbert Graf, Professor MD

Marcel Meyerheim, M.Sc.

Petr Lokaj, MD

Jana Didi, Magister

Annette Sander, MD

Kasra Mirzaie, M.Sc.

Kostas Stamatopoulos, MD

Norbert Grad, Professor MD

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.

The study is designed as observational prospective feasibility study. The main objective is to assess the feasibility of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems, which aim at supporting the communication between the patients, their parents and the treating medical healthcare professionals. Participants of the study are pediatric oncology patients between 6 and 17 years of age and at least one of their parents, receiving treatment at one of the participating clinical centers due to leukemia or solid tumors. With regard to the study, apps have been developed for both groups of participants, which includes inter alia a game in which questions about burden considering symptoms can be answered by the children.

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

The research data will not be published as no consent has been obtained for this. In addition, it is sensitive data derived from a vulnerable patient group, i.e. children in palliative care.

The research results will only be published in anonymized form and after statistical and qualitative evaluation.

The study protocol will be published in a scientific journal. The analyses will be conducted until the end of the project. Publications will be made in accordance with the established criteria for publication of the research results, which can be found in the study protocol, as well as in accordance with national data protection guidelines and internationally applicable provisions of the basic data protection regulation.

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.

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.

Min Value: 0, Max Value: 100, higher scores indicate a better outcome. Quantitative data 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.

Qualitative data 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.

Min Value: 0, Max Value: 5, higher scores indicate a worse outcome. To assess children's symptom burden through an in-game ePRO and optionally as standalone ePRO which can be completed outside the serious game.Further, this contributes to the evidence-base of the effectiveness of ePROs in palliative and supportive care for children with cancer.

Min Value: 0, Max Value: 100, higher scores indicate a better outcome. To demonstrate the appropriateness and acceptability of measures of quality of life of children with cancer.

Min Value: 0, Max Value: 100, higher scores indicate a better outcome. To demonstrate the appropriateness and acceptability of measures of parents' satisfaction with cancer care, i.e. the parents' perception of the quality of medical and nursing care as well as the evaluation of the care's organization and the oncology department services. Furthermore to determine usage and evaluation of the MyPal apps including the gamified ePRO for children with cancer.

Higher scale scores indicate a worse outcome. To demonstrate the appropriateness and acceptability of measures of the impact of pediatric illness on the family, specifically with regards to financial impact, family-social impact and personal strain.

Min Value: 11111, Max Value: 33333, higher scores indicate a worse outcome. To demonstrate the appropriateness and acceptability of measures of parents' quality of life having children with cancer. It will be evaluated with regard to the five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Higher scores indicate a worse outcome. To determine the impact on health care professionals across Europe due to the integration of ePROs in palliative care by measuring strain parameters etc. caused by the usage of the service which is subject of the study. Furthermore, to contribute to the evidence-base of the effectiveness of ePROs for palliative care for children with cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients	NCT04381221	Leukemia, Child... Solid Tumor, Ch...		6 Years - 17 Years	Centre for Research and Technology Hellas
Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients	NCT04381221	Leukemia, Child... Solid Tumor, Ch...		6 Years - 17 Years	Centre for Research and Technology Hellas

Spots Global Cancer Trial Database for supportive care for children