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Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients (MyPal4Kids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381221
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Collaborators:
Saarland University
Brno University Hospital
Hannover Medical School
Information provided by (Responsible Party):
Centre for Research and Technology Hellas

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.

Condition or disease
Leukemia, Childhood Solid Tumor, Childhood

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care




Primary Outcome Measures :
  1. Recruitment rate, defined as percentage of patients eligible for the study from all patients who were screened for the study. [ Time Frame: Regularly each month in the course of 6-month course of study enrollment. ]
    This contributes to the primary study objective: to assess the feasibility and acceptability of as well as the engagement with 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.

  2. 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 [ Time Frame: Regularly each month in the course of 6-month course of study enrollment ]

    This contributes to the primary study objective:

    to assess the feasibility and acceptability of as well as the engagement with 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.


  3. Adherence rate to the different components of the MyPal services by documentation of user behavior and qualitative analysis [ Time Frame: Regularly each month in the course of 6-month course of study enrollment ]
    This contributes to the primary study objective: to assess the feasibility and acceptability of as well as the engagement with 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.

  4. 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) [ Time Frame: Regularly each month in the course of 6-month course of study enrollment ]
    This contributes to the primary study objective: to assess the feasibility and acceptability of as well as the engagement with 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.

  5. System Usability Scale [ Time Frame: At the end of the 6-month course of study enrollment ]
    Min Value: 0, Max Value: 100, higher scores indicate a better outcome. Quantitative data to assess the feasibility and acceptability of as well as the engagement with 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.

  6. Structured Interviews and Focus Groups [ Time Frame: At the end of the 6-month course of study enrollment ]
    Qualitative data to assess the feasibility and acceptability of as well as the engagement with 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.


Secondary Outcome Measures :
  1. Digital adaption of the Mini-SSpedi / SSPedi questionnaires as ePRO. [ Time Frame: 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. ]
    Min Value: 0, Max Value: 5, higher scores indicate a worse outcome. To determine usage and evaluation of the MyPal apps including a gamified ePRO by children with cancer to assess children's symptom burden through an in-game ePRO and optionally as standalone ePRO which can be completed outside the serious game.Further, this contributes to the evidence-base of the effectiveness of ePROs in palliative and supportive care for children with cancer.

  2. PedsQL(TM) Cancer Module questionnaire as ePRO. [ Time Frame: Once at baseline and each month during the 6-month course of study enrollment. ]
    Min Value: 0, Max Value: 100, higher scores indicate a better outcome. To demonstrate the appropriateness and acceptability of measures of quality of life of children with cancer.

  3. EORTC PATSAT C-33 questionnaire, adapted appropriately as ePRO to consider parents' perception. [ Time Frame: Once at baseline and each month during the 6-month course of study enrollment. ]
    Min Value: 0, Max Value: 100, higher scores indicate a better outcome. To demonstrate the appropriateness and acceptability of measures of parents' satisfaction with cancer care, i.e. the parents' perceiption of the quality of medical and nursing care as well as the evaluation of the care's organization and the oncology department services.

  4. Impact on Family Scale questionnaire as ePRO. [ Time Frame: Once at baseline and each month during the 6-month course of study enrollment. ]
    Higher scale scores indicate a worse outcome. To demonstrate the appropriateness and acceptability of measures of the impact of pediatric illness on the family, specifically with regards to financial impact, family-social impact and personal strain.

  5. EQ-5D-3L questionnaire as ePRO. [ Time Frame: Once at baseline and each month during the 6-month course of study enrollment. ]
    Min Value: 11111, Max Value: 33333, higher scores indicate a worse outcome. To demonstrate the appropriateness and acceptability of measures of parents' quality of life having children with cancer. It will be evaluated with regard to the five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  6. Uniquely developed web-based online questionnaire. [ Time Frame: Once at the end of the overall course of the study or earlier given the case of changing study staff. ]
    Higher scores indicate a worse outcome. To determine the impact on health care professionals across Europe due to the integration of ePROs in palliative care by measuring strain parameters etc. caused by the usage of the service which is subject of the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381221


Contacts
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Contact: Norbert Graf, Professor MD +49 68411628411 graf@uks.eu
Contact: Marcel Meyerheim, M.Sc. +49 68411628045 marcel.meyerheim@uks.eu

Locations
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Czechia
University Hospital Brno
Brno, Mähren, Czechia, 62500
Contact: Petr Lokaj, MD       PLokaj@seznam.cz   
Contact: Jana Didi, Magister       Didi.Jana@fnbrno.cz   
Germany
Medical School Hannover
Hannover, Lower Saxony, Germany, 30625
Contact: Annette Sander, MD       Sander.Annette@mh-hannover.de   
Contact: Kasra Mirzaie, M.Sc.       Mirzaie.Kasra@mh-hannover.de   
Saarland University
Homburg, Saarland, Germany, 66424
Contact: Norbert Graf, Professor MD    +49 68411628411    graf@uks.eu   
Contact: Marcel Meyerheim, M.Sc.    +49 68411628045    marcel.meyerheim@uks.eu   
Sponsors and Collaborators
Centre for Research and Technology Hellas
Saarland University
Brno University Hospital
Hannover Medical School
Investigators
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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 Saarland University
Principal Investigator: Norbert Grad, Professor MD Saarland University

Additional Information:
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Responsible Party: Centre for Research and Technology Hellas
ClinicalTrials.gov Identifier: NCT04381221    
Other Study ID Numbers: MyPal4Kids
DRKS00021458 ( Registry Identifier: German Clinical Trials Register )
825872 ( Other Grant/Funding Number: Horizon 2020 Grant Agreement Number )
U1111-1251-0043 ( Registry Identifier: Universal Trial Number (WHO) )
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre for Research and Technology Hellas:
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