Impact of using a mobile protective pod (MOBY) on the quality of life within pediatric hematooncologic patients being severely immunocompromised – prospective cohort study of a single center trial

Not Applicable

Conditions: Immunocompromised pediatric patients undergoing allogeneic or autologous hematopoietic stem cell transplantation or receiving high-dose chemotherapy

Registration Number: DRKS00032818

Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Occurrence of febrile neutropenia (number of episodes)<br>MOBY usage time per patient<br>Day of first mobilization after stem cell transplant/high-dose chemotherapy<br>Duration of parenteral nutrition after stem cell transplantation/high-dose chemotherapy<br>Inpatient readmission to hospital (up to three months after discharge)<br>Post-traumatic symptoms in the follow-up after 3 months (assessed by the CRIES-8)