Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
MyPal4Kids
Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
4 other identifiers
observational
100
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedStudy Start
First participant enrolled
December 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMarch 29, 2022
March 1, 2022
1.7 years
April 27, 2020
March 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Recruitment rate, defined as percentage of patients eligible for the study from all patients who were screened for the study.
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care and pediatric oncology by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Regularly each month in the course of 6-month course of study enrollment.
Participation rate, defined as percentage of recruited patients who completed at least 70% of the scheduled questionnaires for 6 months out of all patients eligible for the study
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Regularly each month in the course of 6-month course of study enrollment
Adherence rate to the different components of the MyPal services by documentation of user behavior and qualitative analysis
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Regularly each month in the course of 6-month course of study enrollment
Premature discontinuation rate, defined as percentage of recruited patients who have not been followed-up until the end of 6-month course of study enrollment (withdrawal, death or less than 70% completed questionnaires)
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Regularly each month in the course of 6-month course of study enrollment
System Usability Scale
Min Value: 0, Max Value: 100, higher scores indicate a better outcome. Quantitative data to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
At the end of the 6-month course of study enrollment
Structured Interviews and Focus Groups
Qualitative data to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
At the end of the 6-month course of study enrollment
Secondary Outcomes (6)
Digital adaption of the Mini-SSpedi / SSPedi questionnaires as ePRO.
Once at baseline and several times a week during the 6-month course of study enrollment. The frequency of single questions depends on severity of reported symptom burden.
PedsQL(TM) Cancer Module questionnaire as ePRO.
Once at baseline and each month during the 6-month course of study enrollment.
EORTC PATSAT C-33 questionnaire, adapted appropriately as ePRO to consider parents' perception.
Once at baseline and each month during the 6-month course of study enrollment.
Impact on Family Scale questionnaire as ePRO.
Once at baseline and each month during the 6-month course of study enrollment.
EQ-5D-3L questionnaire as ePRO.
Once at baseline and each month during the 6-month course of study enrollment.
- +1 more secondary outcomes
Eligibility Criteria
Participants will be recruited in each of the three participating clinical centers. Besides the children patients, an additional group of participants is constituted by the corresponding child's parents. At least one of the parents will be asked to participate in the study as well.
You may qualify if:
- 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)
- 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)
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre for Research and Technology Hellaslead
- Universität des Saarlandescollaborator
- Brno University Hospitalcollaborator
- Hannover Medical Schoolcollaborator
Study Sites (3)
University Hospital Brno
Brno, Mähren, 62500, Czechia
Medical School Hannover
Hanover, Lower Saxony, 30625, Germany
Saarland University
Homburg, Saarland, 66424, Germany
Related Publications (2)
Payne S, Begovic D, Salifu Y, Nelson A, Payne C, Downing J, Natsiavas P, Ling J. Applying Digital Health in Cancer and Palliative Care in Europe: Policy Recommendations from an International Expert Workshop (MyPal Project). J Palliat Med. 2024 Feb;27(2):216-223. doi: 10.1089/jpm.2023.0309. Epub 2023 Sep 22.
PMID: 37738323DERIVEDMeyerheim M, Karamanidou C, Payne S, Garani-Papadatos T, Sander A, Downing J, Stamatopoulos K, Ling J, Payne C, Scarfo L, Lokaj P, Maramis C, Graf N. MyPal-Child study protocol: an observational prospective clinical feasibility study of the MyPal ePRO-based early palliative care digital system in paediatric oncology patients. BMJ Open. 2021 Apr 13;11(4):e045226. doi: 10.1136/bmjopen-2020-045226.
PMID: 33849855DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kostas Stamatopoulos, MD
Representative of the Sponsor: Centre for Research & Technology Hellas
- PRINCIPAL INVESTIGATOR
Annette Sander, MD
Medical School Hannover
- PRINCIPAL INVESTIGATOR
Petr Lokaj, MD
University Hospital Brno
- STUDY DIRECTOR
Norbert Graf, Professor MD
Universität des Saarlandes
- PRINCIPAL INVESTIGATOR
Norbert Grad, Professor MD
Universität des Saarlandes
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
May 8, 2020
Study Start
December 22, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
The research data will not be published as no consent has been obtained for this. In addition, it is sensitive data derived from a vulnerable patient group, i.e. children in palliative care. The research results will only be published in anonymized form and after statistical and qualitative evaluation. The study protocol will be published in a scientific journal. The analyses will be conducted until the end of the project. Publications will be made in accordance with the established criteria for publication of the research results, which can be found in the study protocol, as well as in accordance with national data protection guidelines and internationally applicable provisions of the basic data protection regulation.