Clinical trial NCT02410252: Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies
Official title: Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppresive Therapies for Acute Leukemia and Other Childhood Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Non-Hodgkin Lymphoma
Keywords: continuous temperature monitoring
patient self-management
iThermonitor
Home monitoring
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2015-04-07
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Dyad consists of a pediatric patient aged 2-17 years undergoing myelosuppressive therapies for acute leukemias and other childhood cancers.
* Dyad also includes a caregiver, ≥ 18 years of age that is willing to participate in the study.
* Ability of caregiver or patient (if old enough) to read and speak English.
* If applicable, willingness of the patient to shave axillary (armpit) hair.
* Caregiver (parent or legal guardian) must give informed consent for dyad participation.

Exclusion Criteria:

* Patient has a history of allergy to hydrogel dressing or ongoing skin diseases
* Patients with ongoing febrile illness or documented infectious disease.

Primary outcomes:
measure: Percent of Participants That Successfully Used the iThermonitor
timeFrame: Two Weeks
Secondary outcomes:
measure: Care Giver Anxiety
timeFrame: 0 & 2 weeks
measure: Usability, Acceptability and Satisfaction
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Amanda Centi
state: Massachusetts
Study officials:
affiliation: Partners Connected Health Innovations
name: Stephen Agboola, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kakarmath SS, de Redon E, Centi AJ, Palacholla R, Kvedar J, Jethwani K, Agboola S. Assessing the Usability of an Automated Continuous Temperature Monitoring Device (iThermonitor) in Pediatric Patients: Non-Randomized Pilot Study. JMIR Pediatr Parent. 2018 Dec 21;1(2):e10804. doi: 10.2196/10804.