Clinical trial NCT05180838: Remote Temperature Data for Early Detection of Febrile Neutropenia
Official title: Remote Data Capture of Elevated Temperature Data for Early Detection of Febrile Neutropenia in Patients With Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Malignancy
Keywords: Cytotoxic Chemotherapy
Stem cell transplant
CAR T-cell treatments
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: BioIntelliSense, Inc
First posted: 2022-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 patients with leukemia, lymphoma, myeloma and other blood cancers undergoing treatment with cytotoxic chemotherapy, stem cell transplant or CAR T-cells following IRB consent. Patients will be included who are \>18 years old, 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, are capable of informed consent and agree to collect a self-check temperature log.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reliability of BioSticker compared to self-check
timeFrame: 28 days
Secondary outcomes:
measure: BioSticker Impact on Patient reported temperature
timeFrame: 28 days
measure: BioSticker Impact on Length of Hospitalization
timeFrame: 28 days
measure: BioSticker Impact on ICU transfers
timeFrame: 28 days
measure: BioSticker Impact on Delays in Chemotherapy
timeFrame: 28 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Colorado Research Center
state: Colorado
city: Denver
country: United States
facility: UCHealth-Metro Denver
state: Colorado
Study officials:
affiliation: Colorado Research Center
name: Glen Peterson
role: PRINCIPAL_INVESTIGATOR
References: