NCT04381221

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Centre for Research and Technology Hellas · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Childhood
• Solid Tumor, Childhood

Timeline

• Start date: 2020-12-22
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-05-08
• Last updated: 2022-03-29

Locations

3 sites across 2 countries: Czechia, Germany