Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)

January 10, 2022 updated by: Malaghan Institute of Medical Research

Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)

The THERMAL study is a pilot study to determine feasibility of using two separate continuous skin temperature monitors during intensive treatment for haematological malignancies. It involves participants wearing both the TempTraq and CORE temperature devices for up to 14 days, and then assessing their feasibility and tolerability with quantitative, semiquantitative and qualitative methods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with haematological malignancies such as leukaemia, lymphoma and myeloma often require intensive treatments such as chemotherapy, stem cell transplantation (either autologous or allogeneic) or CAR T-cell therapy. All these therapies can lead to a period of prolonged neutropenia, or low neutrophils, when they are at very high risk of serious bacterial infections. While other countries use routine prophylactic antibiotics, Australasian practice is to focus on prompt recognition and treatment of infections. There is clear evidence that early recognition and treatment of febrile neutropenia with antibiotics leads to improved outcomes, with each hour delay in antibiotic administration associated with an 18% increase in mortality.

Current practice is to detect fevers by both routine and symptom-based intermittent ear thermometer testing, with routine monitoring being approximately every four hours. However, neutropenic patients may not develop symptoms before manifesting a fever, meaning that continuous temperature monitoring could potentially lead to earlier recognition and treatment of febrile neutropenia.

This pilot study seeks to determine the feasibility of using two separate continuous skin temperature monitors during intensive treatment for haematological malignancies, in the inpatient and outpatient setting. If feasible, this could be used to increase the amount of treatments that can be safely performed as outpatients, as well as allowing earlier identification and treatment of febrile neutropenia.

The two proposed measuring devices are: 1. TempTraq adhesive temperature sensor, a skin temperature sensor which is applied to the axilla for 72 hours, then replaced; and 2. CORE temperature sensor, a rechargeable skin temperature sensor that is attached to the chest with a chest strap.

The TempTraq device is an FDA cleared class 2 medical device, while the CORE temperature monitor has received emergency FDA approval as a medical device in the context of the COVID-19 pandemic.

If these devices are demonstrated to be feasible, the technology could potentially be used to improve monitoring of immunosuppressed patients out of hospital, allowing patients to receive treatment out of hospital or closer to home. It may also allow earlier detection of febrile neutropenia, and reduce the mortality from this.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This pilot study aims to recruit 15-20 participants undergoing treatment at Wellington Regional Hospital between November 2021 and June 2022. These will be patients with either acute leukaemia, lymphoma or myeloma that are requiring intensive treatment for their haematological malignancy, such as induction chemotherapy (e.g. doxorubicin/cytarabine for acute myeloid leukaemia), autologous stem cell transplantation, allogeneic stem cell transplantation or chimaeric antigen receptor (CAR) T-cell therapy. Their treatment may be delivered as an inpatient or outpatient (with outpatient treatment more likely in the setting of autologous stem cell transplantation or CAR T-cell therapy).

Description

Inclusion Criteria:

  • Age 16-75 years
  • Diagnosis of acute leukaemia, lymphoma or myeloma by consultant haematologist or multidisciplinary meeting discussion
  • Undergoing treatment with either induction chemotherapy, autologous stem cell transplant, allogeneic stem cell transplant, or chimeric antigen receptor (CAR) T-cell therapy as part of their normal care.

Exclusion Criteria:

  • Medical condition that would result in discomfort from the application of chest or axillary monitoring.
  • Allergy to a component of the monitoring devices
  • Diminished capacity or any circumstance that would prohibit them from understanding and providing informed consent in accordance with ICH-GCP (International Conference on Harmonisation, Good Clinical Practice) principles.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observation group
Group of participants wearing continuous temperature monitoring device
Device: TempTraq temperature monitor
All participants will wear both TempTraq temperature monitor and CORE temperature monitor.
Other Names:
  • CORE temperature monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time device was worn
Time Frame: 14 days
Percentage of time that both CORE and TempTraq were worn against total time available
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device usability based on System Usability Scale questionnaire
Time Frame: 12 days
Comparison of results from System Usability Scale (SUS) questionnaire for both devices at day 4, 8 and 12. The SUS is reported on a scale of 1-5, with 5 indicating the best response.
12 days
Participant interest in device, based on Intrinsic Motivation Index questionnaire
Time Frame: 12 days
Comparison of results from Intrinsic Motivation Index questionnaires for both devices at day 4, 8 and 12. The IMI is reported on a 1-6 scale, with 6 in general indicating a better outcome (however several questions require the result to be reversed).
12 days
Participant preference for TempTraq or CORE device
Time Frame: 14 days
Whether participant had a preference for once device over the other at completion of monitoring. This is to be indicated with a binary "TempTraq or CORE" question.
14 days
Comparability to intermittent ear thermometer data
Time Frame: 14 days
Whether the TempTraq and CORE recordings correlated to intermittent ear thermometer recordings at the same timepoints (intermittent ear thermometers being the current standard of care).
14 days
Time between fever identification
Time Frame: 14 days
Difference in time between fever identification via TempTraq and CORE temperature devices and intermittent ear thermometer
14 days
Rates of skin irritation or infection
Time Frame: 14 days
Percentage of devices noted to have skin irritation or infection.
14 days
Participant age in years
Time Frame: 14 days
Age in years, to be reported with median and range, to allow description of participant characteristics
14 days
Participant ethnicity
Time Frame: 14 days
Participant self-identification of ethnicity, as per New Zealand Ministry of Health Ethnicity Data Protocols, Level 1 numbering hierarchy (as described in: https://www.health.govt.nz/publication/hiso-100012017-ethnicity-data-protocols)
14 days
Participant diagnosis
Time Frame: 14 days
Histological classification of diagnosis, as per World Health Organisation classification of haematological malignancies.
14 days
Participant body mass index
Time Frame: 14 days
Body mass index at enrolment in kg/m2, using height and weight.
14 days
Haematological treatment that participant is undergoing during study period
Time Frame: 14 days
Haematological treatment, such as chemotherapy, cellular therapy e.g. CAR T-cell therapy, or stem cell therapy (whether allogeneic or autologous).
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malaghan Institute of Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21/161

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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