Sponsor:
Centre for Research and Technology Hellas
Collaborator:
Universität des Saarlandes, Brno University Hospital, Hannover Medical School,
Studienleiter
Kostas Stamatopoulos, MD Study Chair Representative of the Sponsor: Centre for Research & Technology Hellas Annette Sander, MD Principal Investigator Medical School Hannover Petr Lokaj, MD Principal Investigator University Hospital Brno Norbert Graf, Professor MD Study Director Universität des Saarlandes Norbert Grad, Professor MD Principal Investigator Universität des Saarlandes
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
Secondary outcome:
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 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' perception of the quality of medical and nursing care as well as the evaluation of the care's organization and the oncology department services. Furthermore to determine usage and evaluation of the MyPal apps including the gamified ePRO for children with cancer.
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. Furthermore, to contribute to the evidence-base of the effectiveness of ePROs for palliative care for children with cancer
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients"
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