Clinical trial NCT04381221: Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
Official title: Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia, Childhood
Solid Tumor, Childhood
Keywords: Patient-Reported Outcome (PRO)
electronic Patient-Reported Outcome (ePRO)
Patient-Reported Outcome Measure (PROM)
Palliative Care for Children
Supportive Care for Children
Serious Game
eHealth
Mobile Applications
Observative Study
Lead sponsor: Centre for Research and Technology Hellas
Sponsor class: OTHER
Collaborators: name: Universität des Saarlandes
name: Brno University Hospital
name: Hannover Medical School
First posted: 2020-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Recruitment rate, defined as percentage of patients eligible for the study from all patients who were screened for the study.
timeFrame: Regularly each month in the course of 6-month course of study enrollment.
measure: 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
timeFrame: Regularly each month in the course of 6-month course of study enrollment
measure: Adherence rate to the different components of the MyPal services by documentation of user behavior and qualitative analysis
timeFrame: Regularly each month in the course of 6-month course of study enrollment
measure: 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)
timeFrame: Regularly each month in the course of 6-month course of study enrollment
measure: System Usability Scale
timeFrame: At the end of the 6-month course of study enrollment
measure: Structured Interviews and Focus Groups
timeFrame: At the end of the 6-month course of study enrollment
Secondary outcomes:
measure: Digital adaption of the Mini-SSpedi / SSPedi questionnaires as ePRO.
timeFrame: 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.
measure: PedsQL(TM) Cancer Module questionnaire as ePRO.
timeFrame: Once at baseline and each month during the 6-month course of study enrollment.
measure: EORTC PATSAT C-33 questionnaire, adapted appropriately as ePRO to consider parents' perception.
timeFrame: Once at baseline and each month during the 6-month course of study enrollment.
measure: Impact on Family Scale questionnaire as ePRO.
timeFrame: Once at baseline and each month during the 6-month course of study enrollment.
measure: EQ-5D-3L questionnaire as ePRO.
timeFrame: Once at baseline and each month during the 6-month course of study enrollment.
measure: Uniquely developed web-based online questionnaire.
timeFrame: Once at the end of the overall course of the study or earlier given the case of changing study staff.
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
state: Mähren
city: Hannover
country: Germany
facility: Medical School Hannover
state: Lower Saxony
city: Homburg
country: Germany
facility: Saarland University
state: Saarland
Study officials:
affiliation: Representative of the Sponsor: Centre for Research & Technology Hellas
name: Kostas Stamatopoulos, MD
role: STUDY_CHAIR
affiliation: Medical School Hannover
name: Annette Sander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Brno
name: Petr Lokaj, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universität des Saarlandes
name: Norbert Graf, Professor MD
role: STUDY_DIRECTOR
affiliation: Universität des Saarlandes
name: Norbert Grad, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyerheim 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.