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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05203809
Registration number
NCT05203809
Ethics application status
Date submitted
22/11/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Titles & IDs
Public title
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies
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Scientific title
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
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Secondary ID [1]
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H21/161
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Universal Trial Number (UTN)
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Trial acronym
THERMAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Haematological Malignancy
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Leukemia
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Lymphoma
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Myeloma
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Temperature Change, Body
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Blood
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0
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Other blood disorders
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Metabolic and Endocrine
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0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - TempTraq temperature monitor
Observation group - Group of participants wearing continuous temperature monitoring device
Treatment: Devices: TempTraq temperature monitor
All participants will wear both TempTraq temperature monitor and CORE temperature monitor.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time device was worn
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Assessment method [1]
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Percentage of time that both CORE and TempTraq were worn against total time available
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Timepoint [1]
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14 days
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Secondary outcome [1]
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Device usability based on System Usability Scale questionnaire
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Assessment method [1]
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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.
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Timepoint [1]
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12 days
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Secondary outcome [2]
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Participant interest in device, based on Intrinsic Motivation Index questionnaire
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Assessment method [2]
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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).
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Timepoint [2]
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12 days
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Secondary outcome [3]
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Participant preference for TempTraq or CORE device
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Assessment method [3]
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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.
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Timepoint [3]
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14 days
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Secondary outcome [4]
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Comparability to intermittent ear thermometer data
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Assessment method [4]
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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).
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Timepoint [4]
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14 days
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Secondary outcome [5]
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Time between fever identification
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Assessment method [5]
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Difference in time between fever identification via TempTraq and CORE temperature devices and intermittent ear thermometer
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Timepoint [5]
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14 days
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Secondary outcome [6]
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Rates of skin irritation or infection
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Assessment method [6]
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Percentage of devices noted to have skin irritation or infection.
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Timepoint [6]
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14 days
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Secondary outcome [7]
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Participant age in years
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Assessment method [7]
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Age in years, to be reported with median and range, to allow description of participant characteristics
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Timepoint [7]
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14 days
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Secondary outcome [8]
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Participant ethnicity
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Assessment method [8]
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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)
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Timepoint [8]
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14 days
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Secondary outcome [9]
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Participant diagnosis
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Assessment method [9]
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Histological classification of diagnosis, as per World Health Organisation classification of haematological malignancies.
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Timepoint [9]
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14 days
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Secondary outcome [10]
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Participant body mass index
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Assessment method [10]
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Body mass index at enrolment in kg/m2, using height and weight.
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Timepoint [10]
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14 days
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Secondary outcome [11]
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Haematological treatment that participant is undergoing during study period
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Assessment method [11]
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Haematological treatment, such as chemotherapy, cellular therapy e.g. CAR T-cell therapy, or stem cell therapy (whether allogeneic or autologous).
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Timepoint [11]
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14 days
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Eligibility
Key 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.
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Minimum age
16
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2022
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Malaghan Institute of Medical Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05203809
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05203809
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