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

Sponsor

Malaghan Institute of Medical Research (Other)

Overall Status

Recruiting

CT.gov ID

NCT05203809

Collaborator

(none)

Enrollment

Location

7.4

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Haematological Malignancy Leukemia Lymphoma Myeloma Temperature Change, Body	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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 18, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Time device was worn [14 days]
Percentage of time that both CORE and TempTraq were worn against total time available

Secondary Outcome Measures

Device usability based on System Usability Scale questionnaire [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.
Participant interest in device, based on Intrinsic Motivation Index questionnaire [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).
Participant preference for TempTraq or CORE device [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.
Comparability to intermittent ear thermometer data [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).
Time between fever identification [14 days]
Difference in time between fever identification via TempTraq and CORE temperature devices and intermittent ear thermometer
Rates of skin irritation or infection [14 days]
Percentage of devices noted to have skin irritation or infection.
Participant age in years [14 days]
Age in years, to be reported with median and range, to allow description of participant characteristics
Participant ethnicity [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)
Participant diagnosis [14 days]
Histological classification of diagnosis, as per World Health Organisation classification of haematological malignancies.
Participant body mass index [14 days]
Body mass index at enrolment in kg/m2, using height and weight.
Haematological treatment that participant is undergoing during study period [14 days]
Haematological treatment, such as chemotherapy, cellular therapy e.g. CAR T-cell therapy, or stem cell therapy (whether allogeneic or autologous).

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.