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

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: Lymphoma; Leukemia; Myeloma; Temperature Change, Body; Haematological Malignancy
• Intervention / Treatment: Device: TempTraq temperature monitor

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

Study Locations

• New Zealand
  • Wellington, New Zealand, 6012
    • Recruiting
    • Malaghan Institute of Medical Research
    • Contact: Robert C Fyfe, MBChB; Phone Number: 0064212066662; Email: rfyfe@malaghan.org.nz
    • Contact: Robert Weinkove, MBBS, PhD; Phone Number: 0064221746400; Email: rweinkove@malaghan.org.nz

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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	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	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	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	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	Difference in time between fever identification via TempTraq and CORE temperature devices and intermittent ear thermometer	14 days
Rates of skin irritation or infection	Percentage of devices noted to have skin irritation or infection.	14 days
Participant age in years	Age in years, to be reported with median and range, to allow description of participant characteristics	14 days
Participant ethnicity	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	Histological classification of diagnosis, as per World Health Organisation classification of haematological malignancies.	14 days
Participant body mass index	Body mass index at enrolment in kg/m2, using height and weight.	14 days
Haematological treatment that participant is undergoing during study period	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

• Sponsor: Malaghan Institute of Medical Research

Study record dates

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: febrile neutropenia; temperature monitor; continuous; wireless
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neoplasms; Hematologic Neoplasms; Neutropenia; Febrile Neutropenia; Body Temperature Changes
• 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