Remote Temperature Data for Early Detection of Febrile Neutropenia

Study Overview
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Brief Summary
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BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of  1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.

Detailed Description
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The BioIntelliSense BioSticker potentially offers a solution to these challenges through early and reliable detection of elevated temperature and perhaps other relevant physiologic changes. The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring (see https://biointellisense.com as well as attached documents on BioSticker instructions for a full description and use instructions). The BioSticker detects the following: Respiratory rate, heart rate at rest and skin temperature Body position, activity levels, sleep status High-resolution gait analysis and fall detection Symptomatic events BioSticker data is remotely tracked and displayed in a report termed the BioReport for retrospective data analysis. Typically, the biosensor collects data on an interval of  1 minute and this data is collated and reported remotely back to the BioReport every 6 hours. More importantly, for future applications of the BioSticker for early detection of FN, there are ongoing efforts to implement real time reporting and alarms using remote monitoring services that could alert the patient that they need to seek medical care. There are no known deleterious effects from the BioSticker and it is now being widely used and tested in diverse applications including detection and contact tracing of COVID and others.

Official Title
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Remote Data Capture of Elevated Temperature Data for Early Detection of Febrile Neutropenia in Patients With Hematologic Malignancies

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Device: BioSticker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-80 years (inclusive) Provision to sign and date the consent form. Diagnosed with a hematologic malignancy and undergoing cytotoxic chemotherapy, stem cell transplants or CAR T-cell treatments at the Blood Disorders and Cell Therapies Center at UCHealth (BDCTC) Will have longitudinal care provided by the BDCTC for >1 additional month Receive chemotherapy or other therapies known to cause reductions in WBC <1000 on a routine basis Scheduled to be discharged home and self-monitor for FN and other complications Patient is willing to tell TSA or any security representative that you are wearing a medical device Patient has agreed to not submerge the device underwater including while swimming or bathing Patient is willing to complete a self-check temperature log comply and be available for the duration of the study Patient has access to a thermometer Exclusion Criteria: Patient that wears a defibrillator, pacemaker, or other implantable device Patient has broken skin including wounds, sores, or abrasions in the area that the BioSticker would be applied Patient has had a severe reaction to silicone adhesives Patient has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BioSticker<br>This cohort will place BioStickers at least 3 days prior to completion of standard of care therapy and discharge home post therapy. | Device: BioSticker<br>* The BioSticker is an FDA approved medical device which can be worn on the upper left chest for remote data capture and can provide for up 30 days of continuous vital sign monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of BioSticker compared to self-check | Patients will self-temperature check every 6 hours or at least two times per day, and will log these temperatures in a paper record with date, time and temperature noted. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BioSticker Impact on Patient reported temperature | Patients will report a single oral temperature of ≥38.3°C (101°F) or a temperature of ≥38.0°C (100.4°F) sustained over a one-hour period to our clinic nurses or 24/7 on-call advanced practitioner and will be directed to the Emergency Department or clinic for initiation of antibiotics and FN work-up and management as per usual practice. | 28 days | 
| BioSticker Impact on Length of Hospitalization | Hospitalization during the 28 days will be extracted from the medical record | 28 days | 
| BioSticker Impact on ICU transfers | ICU transfers during the 28 days will be extracted from the medical record | 28 days | 
| BioSticker Impact on Delays in Chemotherapy | Delays in chemotherapy during the 28 days will be extracted from the medical record | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytotoxic Chemotherapy, Stem cell transplant, CAR T-cell treatments