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Brief Title: Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
Official Title: Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
Study ID: NCT04381221
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 6 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
University Hospital Brno, Brno, Mähren, Czechia
Medical School Hannover, Hannover, Lower Saxony, Germany
Saarland University, Homburg, Saarland, Germany
Name: Kostas Stamatopoulos, MD
Affiliation: Representative of the Sponsor: Centre for Research & Technology Hellas
Role: STUDY_CHAIR
Name: Annette Sander, MD
Affiliation: Medical School Hannover
Role: PRINCIPAL_INVESTIGATOR
Name: Petr Lokaj, MD
Affiliation: University Hospital Brno
Role: PRINCIPAL_INVESTIGATOR
Name: Norbert Graf, Professor MD
Affiliation: Universität des Saarlandes
Role: STUDY_DIRECTOR
Name: Norbert Grad, Professor MD
Affiliation: Universität des Saarlandes
Role: PRINCIPAL_INVESTIGATOR