Status:
UNKNOWN
Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
Lead Sponsor:
Centre for Research and Technology Hellas
Collaborating Sponsors:
Universität des Saarlandes
Brno University Hospital
Conditions:
Leukemia, Childhood
Solid Tumor, Childhood
Eligibility:
All Genders
6-17 years
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 de...
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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04381221
Start Date
December 22 2020
End Date
September 1 2022
Last Update
March 29 2022
Active Locations (3)
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1
University Hospital Brno
Brno, Mähren, Czechia, 62500
2
Medical School Hannover
Hanover, Lower Saxony, Germany, 30625
3
Saarland University
Homburg, Saarland, Germany, 66424