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

NCT ID: NCT04381221

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2022-09-30

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.

Conditions

Leukemia, Childhood; Solid Tumor, Childhood

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität des Saarlandes

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

Centre for Research and Technology Hellas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kostas Stamatopoulos, MD

Role: STUDY_CHAIR

Representative of the Sponsor: Centre for Research & Technology Hellas

Annette Sander, MD

Role: PRINCIPAL_INVESTIGATOR

Medical School Hannover

Petr Lokaj, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno

Norbert Graf, Professor MD

Role: STUDY_DIRECTOR

Universität des Saarlandes

Norbert Grad, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Universität des Saarlandes

Locations

University Hospital Brno

Brno, Mähren, Czechia

Site Status: RECRUITING

Medical School Hannover

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

Saarland University

Homburg, Saarland, Germany

Site Status: RECRUITING

Countries

Czechia; Germany

Central Contacts

Norbert Graf, Professor MD

Role: CONTACT

graf@uks.eu

+49 68411628411

Marcel Meyerheim, M.Sc.

Role: CONTACT

marcel.meyerheim@uks.eu

+49 68411628045

Facility Contacts

Petr Lokaj, MD

Role: primary

PLokaj@seznam.cz

Jana Didi, Magister

Role: backup

Didi.Jana@fnbrno.cz

Annette Sander, MD

Role: primary

Sander.Annette@mh-hannover.de

Kasra Mirzaie, M.Sc.

Role: backup

Mirzaie.Kasra@mh-hannover.de

Norbert Graf, Professor MD

Role: primary

graf@uks.eu

+49 68411628411

Marcel Meyerheim, M.Sc.

Role: backup

marcel.meyerheim@uks.eu

+49 68411628045

References

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.

Reference Type: DERIVED

PMID: 37738323 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33849855 (View on PubMed)

Related Links

https://mypal-project.eu

MyPal project website

Other Identifiers

DRKS00021458

Identifier Type: REGISTRY

Identifier Source: secondary_id

825872

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U1111-1251-0043

Identifier Type: REGISTRY

Identifier Source: secondary_id

MyPal4Kids

Identifier Type: -

Identifier Source: org_study_id