Immunocompromised pediatric patients undergoing allogeneic or autologous hematopoietic stem cell transplantation or receiving high-dose chemotherapy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients are undergoing allogeneic/autologous hematopoietic stem cell transplantation OR high-dose chemotherapy Age 3 - 17 years at time of inclusion Body weight of patient (and in age group 3-6 years plus companion) is less than 150kg Sufficient German language skills of the participating patients and their parents Written consent from the patient(s) or legal representatives to participate in the present study and to pass on pseudonymized data as part of the documentation Availability for three-month follow-up
Exclusion criteria
Exclusion criteria: Severe acute infection, such as sepsis at inclusion Missing physical mobility of the patient, such as missing ability to sit Patients with severe claustrophobia Acute severe psychiatric disorder before inclusion Severe mental disability Severe language barriers of patient and/or custodians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life assessed in semi-structured qualitative interviews and using the KINDL(R) questionnaire (collected before the first use of MOBY and after 4-6 uses of MOBY) | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of febrile neutropenia (number of episodes) MOBY usage time per patient Day of first mobilization after stem cell transplant/high-dose chemotherapy Duration of parenteral nutrition after stem cell transplantation/high-dose chemotherapy Inpatient readmission to hospital (up to three months after discharge) Post-traumatic symptoms in the follow-up after 3 months (assessed by the CRIES-8) | — |
Countries
Germany
Contacts
Charité - Universitätsmedizin Berlin