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

NCT05203809 | Unknown FDA Device

• 1 other identifier: H21/161
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Haematological Malignancy; Leukemia; Lymphoma; Myeloma; Temperature Change, Body

Keywords

temperature monitor; continuous; wireless; febrile neutropenia

Outcome Measures

Primary Outcomes (1)

• Time device was worn

  Percentage of time that both CORE and TempTraq were worn against total time available

  14 days

Secondary Outcomes (11)

• Device usability based on System Usability Scale questionnaire

  12 days

• Participant interest in device, based on Intrinsic Motivation Index questionnaire

  12 days

• Participant preference for TempTraq or CORE device

  14 days

• Comparability to intermittent ear thermometer data

  14 days

• Time between fever identification

  14 days

Study Arms (1)

Observation group

Group of participants wearing continuous temperature monitoring device

Device: TempTraq temperature monitor

Interventions

TempTraq temperature monitor DEVICE

All participants will wear both TempTraq temperature monitor and CORE temperature monitor.

Also known as: CORE temperature monitor

Observation group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Malaghan Institute of Medical Research: lead

Study Sites (1)

Malaghan Institute of Medical Research

Wellington, 6012, New Zealand

RECRUITING

Related Publications (1)

• Fyfe RC, Larsen M, Blud D, Weinkove R. Continuous temperature monitoring for the detection of fever in haemato-oncology patients: a pilot study of two wearable devices (THERMAL). Intern Med J. 2025 Nov;55(11):1928-1933. doi: 10.1111/imj.70199. Epub 2025 Sep 26.

  PMID: 41001994 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Neoplasms, Plasma Cell; Body Temperature Changes; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 24, 2022
• Study Start: November 18, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

NZ (1)