Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based early Palliative Care Digital System in Paediatric Oncology Patients
- Conditions
- Pediatric Leukemia and solid tumorsAcute leukaemia of unspecified cell typeC00-C97Palliative careMalignant neoplasmsZ51.5C95.0
- Registration Number
- DRKS00021458
- Lead Sponsor
- Centre for Research and Technology Hellas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care and pediatric oncology by adapting and advancing ePRO systems.<br><br>Primary Outcome Measures:<br><br>- Rates of recruitment, participation, adherence and premature discontinuation to the different components of the MyPal digital health platform during study enrolment<br><br>- Quantitative data through System Usability Scale and an adapted version for children at the end of study enrolment<br><br>- Qualitative data through structured interviews and focus groups at the end of study enrolment
- Secondary Outcome Measures
Name Time Method