Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients (MyPal4Kids)

Centre for Research and Technology Hellas

Status: Unknown

Conditions: Solid Tumor, Childhood; Leukemia, Childhood

Study type: Observational

Funder types: Other

Identifiers

NCT04381221

U1111-1251-0043 (Registry Identifier)

DRKS00021458 (Registry Identifier)

825872 (Other Grant/Funding Number)

MyPal4Kids

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.