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Participants are asked to use the iThermonitor device for two weeks to monitor their temperature. Participants are asked to wear the device for as many hours as they can but at a minimum to wear while sleeping.

The device is a continuous temperature monitoring tool for home monitoring of temperature. Participants are asked to use this device for two weeks.

iThermonitor

Stephen Agboola, MD, MPH

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.

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.

Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies

Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppresive Therapies for Acute Leukemia and Other Childhood Cancers

This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. "Time in the study" here is defined as the number of days the subject spends in the study which is expected to be two weeks.

The Generalized Anxiety Disorder, 7 item questionnaire was given to caregivers to see if using the device increased feelings of anxiety. This will be assessed using the GAD-7 questionnaire administered at enrollment and closeout

This will be assessed by questionnaires specifically designed for this study. We will be assessing ease of use, acceptability, connection and use problems like the device falling off the skin, usefulness of out-of-range temperature alerts and adverse reactions. We will also assess to see if the device helps to build caregiver self-efficacy skills in caring for the patient.

Dana-Farber Cancer Institute

Massachusetts General Hospital

Dermatologist

Single group subjects that will use the iThermonitor device to collect temperature information for two weeks.

iThermonitor: The device is a continuous temperature monitoring tool for home monitoring of temperature

Temperature Monitoring Group

This was a single arm usability and feasibility study. All participants were enrolled into the same group where they used the study device to monitor their temperature for two weeks.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Age of Caregivers

Employment Status of Caregivers

One major limitation of our study is the lack of a control group that used another temperature measurement device such as a digital thermometer without a companion app or automated temperature measurement features.

Amanda Centi

Descriptive statistics were used to characterize the study sample, and survey responses.

Only percent will be calculated. No statistical analysis will be conducted.

No statistical analysis was conducted as part of this study.

View data at least once per day

Reported receiving out of range alerts

Reported receiving 3 or more out of range alerts

This was a single arm usability and feasibility study. All participants were enrolled into the same group and monitored their body temperature using the study device for 2 weeks.

Caregivers of participants using the device

Percent of Participants That Successfully Used the iThermonitor

GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).

Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test.

GAD Score_0 Weeks

GAD Score_2 Weeks

This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the study device to monitor body temperature for 2 weeks.

Caregivers of participants using the device.

Care Giver Anxiety

Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study

Satisfied with ease of use of device

Easy to learn to use device

Felt comfortable using device

Able to easily monitor temperature by using device

Feel confident monitoring temperature with device

Device helpful stating discussions with doctor

Using device makes me feel more connected to team

Would recommend device

Found app very useful in monitoring temperature

Found out-of-range temp alert function useful

This was a single arm usability and feasibility study. All participants were enrolled into the same group and asked to monitor their body temperature for 2 weeks using the study device.

Usability, Acceptability and Satisfaction

This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the temperature monitoring device for 2 weeks.

Spots Global Cancer Trial Database for continuous temperature monitoring