In this study the WD will be studied in the patients for 14 days. A total of 20 patients will be included, including at least 4 patients <6 years. As this is a feasibility study, a formal sample size calculation has not been performed. However, this sample size allows to assess the primary outcome with clinically meaningful precision and to roughly assess the primary outcome in the group of patients <6 years of age.
Project population, inclusion and exclusion criteria
· Chemotherapy treatment because of any malignancy, expected to last ≥1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous hematopoietic stem cell transplantation.
· Age from 1 month to 17.99 years at time of recruitment
· Written informed consent from patients and/or parents
· Local skin diseases prohibiting wearing of the WD.
· Denied written informed consent from patients and/or parents
Phases of the study:
Recruitment, screening and informed consent procedure
This study will be conducted at the Inselspital, Bern University Hospital. Patients will be screened for eligibility and recruited by a study investigator or treating physician. Patient recruitment will stop when the aimed number of twenty patients is reached. No payment or compensation will be given to study patients or their parents. The investigators will explain to the parents/legal representative and the patient if applicable, the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. The participation in the study is voluntary and the participants may withdraw from the study at any time. The formal consent of the parents/legal representative and the patient if applicable, using the approved consent form, must be obtained before the patient is submitted to any study procedure.
The study visit will be done during a routine outpatient visit, or during hospitalization. One of the study investigators will distribute the WD, the charger, and if needed a mobile phone to the parents or patient. Parents and/or patients, with no suitable mobile phone, will be provided with a phone for the study time. This phone will not be usable for other purposes than data transfer. Basic characteristics will be assessed at the study visit.
The WD is fitted using body size-appropriate elastic bands and the fitting is controlled by the investigator. Parents and patients if applicable, will be instructed in the handling and charging of the WD. For instructions, the pictures and descriptions provided by the manufacturer on the website, in the “instructions for use” handbook and the information in the study information form will be used. The WD will be put on the upper arm or, if anatomically reasonable, on the upper leg.
There will be no additional examinations or procedures performed for this study, specifically no additional discrete measurements of vital signs will be undertaken unless the clinically indicated measurements. Daily activities and temperature measurements if taken during outpatient stay will be recorded on case report forms (CRF) by parents and/or by patients. Questionnaires will be used for the assessment of WD acceptance, side effects and reasons not to wear the device.
Parents, patients and members of the treating staff will not be able to access the continuously measured data, in order to avoid any influence on clinical decision making due to these data.
During the whole study period, one of the investigators will do a daily data-check, to see if data is recorded properly or not. If no data is recorded or if there are signs for reduced data quality, the parents and/or patients will be contacted by phone. Possible reasons for non-recording or reduced data quality will be discussed on the phone and instructions will be given to parents and/or patients.
During the study period, parents and/or patients will be in charge for battery charging (approx.2 hours each day) and data upload via mobile phone app. Parents and/or patients will fill out a CRF daily and note time of charging, connection to the mobile phone, reasons for not wearing the WD, any side effects, activities and temperature measurements, if applicable.
During hospitalization treating staff will perform discrete measurements as clinically indicated and note them in the patient chart. Parents and/or patients will continue to fill out the CRF daily. The charts will be assessed by the investigators to match the recorded data with the data from the WD.
The study period ends regularly for each patient after the planned period of 14 days, in case of intensive care unit admission or at the day of death from any cause, unrelated to the study.
Follow-up period covers 24hours after the end of the study period. The respective follow-up interview by phone or if applicable during a routine hospital visit will take place 1 to 3 days after the end of the study period.