Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies
Condition: Acute Lymphocytic Leukemia; Acute Myeloid Leukemia; Non-Hodgkin Lymphoma
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      This is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous
      temperature monitoring device, as a clinical support and patient self-management tool in the
      management of pediatrics patients on myelosuppressive therapies for acute leukemia and other
      childhood cancers.
    

Detailed description: 
      Neutropenia, secondary to myelosupressive therapies, predisposes patients to significant risk
      for infectious complications which increases morbidity and mortality. Usually, fever is the
      first clinical sign of the inflammatory response to the infective process; and early
      detection is an indication for empiric antimicrobial therapy and further evaluation to
      determine risk for sepsis. Today, broad-spectrum antimicrobial therapy at the first detection
      of fever has helped significantly decreased the mortality associated with neutropenia in the
      intensive phase of chemotherapy. Therefore, early detection of fever, through regular
      temperature monitoring, in a neutropenic patient is critical to improved clinical outcome.
      Vigilance on the part of care providers and care givers is crucial to early detection.
      Traditionally, this is simply done through episodic oral or axillary monitoring of
      temperature. In this study, we propose to test the use feasibility of an innovative device
      that continuously monitors body temperature as a clinical decision support tool in pediatric
      patients undergoing myelosuppressive therapies for acute leukemias and other childhood
      cancers.

      The iThermonitor, a FDA class II device, is a high accuracy device that continuously monitors
      body temperature and connects to a receiver (iPad mini) via bluetooth to display body
      temperature data in real time. The iThermonitor is attached to the skin by a hydrogel
      dressing which can be changed as needed. It captures data even without connection to a
      receiver and it can establish connection to a paired receiver device (the iPad mini) within a
      range of three meters. The provided iPad mini will be pre-loaded with the iThermonitor app
      which will be used to pair the receiver with the iThermonitor device. The device monitors
      body temperature every four seconds and is able to store 10 days worth of data that can be
      offloaded as soon as it establishes connection with a receiver. It is able to measure
      temperature in the range of 25-45 degrees Celsius. Users are able to set temperature limits
      at which alerts for which out-of-range temperature can go off. It also provides care
      providers an opportunity to remotely monitor their patients' temperature in the immediate
      period after discharge from the hospital. Therefore, we hypothesize that the iThermonitor can
      serve as a feasible clinical decision support in the management of pediatric patients
      undergoing intensive treatments for acute leukemia and other childhood cancers.

      This study will be implemented as a pilot study to test the use feasibility of the
      iThermonitor as a clinical decision support for continuous temperature monitoring in a dyad
      of 25 pediatrics patients, (aged 2yrs - 17yrs) on myelosuppressive therapies for acute
      leukemia and other childhood cancers at the MGH Pediatric Hematology and Oncology group, and
      their caregivers. The iThermonitor will be used by patients and their caregivers at home over
      a 2-week study period starting from the day after chemotherapy. There will be two study
      visits: study enrollment and study closeout.

      The investigators have chosen to implement this study as a feasibility study because the
      investigators' goal is to determine if continuous temperature monitoring by the iThermonitor
      can work in home settings. To the investigators' knowledge, the researchers are not aware of
      any previous research exploring continuous temperature monitoring in pediatric oncology
      patients on myelosuppresive therapies. Therefore, findings from this study have the potential
      to advance knowledge about the management of fever in pediatric patients on myelosuppresive
      therapies.
    

Intervention name(s): iThermonitor
Intervention type(s): Device
Intervention description(s): The device is a continuous temperature monitoring tool for home monitoring of temperature. Participants are asked to use this device for two weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: continuous temperature monitoring; patient self-management; iThermonitor; Home monitoring