Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
Scientific title
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
Query!
Secondary ID [1]
0
0
H21/161
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
THERMAL
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Haematological Malignancy
0
0
Query!
Leukemia
0
0
Query!
Lymphoma
0
0
Query!
Myeloma
0
0
Query!
Temperature Change, Body
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Normal metabolism and endocrine development and function
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time device was worn
Query!
Assessment method [1]
0
0
Percentage of time that both CORE and TempTraq were worn against total time available
Query!
Timepoint [1]
0
0
14 days
Query!
Secondary outcome [1]
0
0
Device usability based on System Usability Scale questionnaire
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 days
Query!
Secondary outcome [2]
0
0
Participant interest in device, based on Intrinsic Motivation Index questionnaire
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
12 days
Query!
Secondary outcome [3]
0
0
Participant preference for TempTraq or CORE device
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
14 days
Query!
Secondary outcome [4]
0
0
Comparability to intermittent ear thermometer data
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
14 days
Query!
Secondary outcome [5]
0
0
Time between fever identification
Query!
Assessment method [5]
0
0
Difference in time between fever identification via TempTraq and CORE temperature devices and intermittent ear thermometer
Query!
Timepoint [5]
0
0
14 days
Query!
Secondary outcome [6]
0
0
Rates of skin irritation or infection
Query!
Assessment method [6]
0
0
Percentage of devices noted to have skin irritation or infection.
Query!
Timepoint [6]
0
0
14 days
Query!
Secondary outcome [7]
0
0
Participant age in years
Query!
Assessment method [7]
0
0
Age in years, to be reported with median and range, to allow description of participant characteristics
Query!
Timepoint [7]
0
0
14 days
Query!
Secondary outcome [8]
0
0
Participant ethnicity
Query!
Assessment method [8]
0
0
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)
Query!
Timepoint [8]
0
0
14 days
Query!
Secondary outcome [9]
0
0
Participant diagnosis
Query!
Assessment method [9]
0
0
Histological classification of diagnosis, as per World Health Organisation classification of haematological malignancies.
Query!
Timepoint [9]
0
0
14 days
Query!
Secondary outcome [10]
0
0
Participant body mass index
Query!
Assessment method [10]
0
0
Body mass index at enrolment in kg/m2, using height and weight.
Query!
Timepoint [10]
0
0
14 days
Query!
Secondary outcome [11]
0
0
Haematological treatment that participant is undergoing during study period
Query!
Assessment method [11]
0
0
Haematological treatment, such as chemotherapy, cellular therapy e.g. CAR T-cell therapy, or stem cell therapy (whether allogeneic or autologous).
Query!
Timepoint [11]
0
0
14 days
Query!
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.
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
UNKNOWN
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/11/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/06/2022
Query!
Actual
Query!
Sample size
Target
20
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Wellington
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Malaghan Institute of Medical Research
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05203809
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05203809
Download to PDF