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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
Scientific title
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignancies (THERMAL)
Secondary ID [1] 0 0
H21/161
Universal Trial Number (UTN)
Trial acronym
THERMAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological Malignancy 0 0
Leukemia 0 0
Lymphoma 0 0
Myeloma 0 0
Temperature Change, Body 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Blood 0 0 0 0
Other blood disorders
Metabolic and Endocrine 0 0 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time device was worn
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Device usability based on System Usability Scale questionnaire
Timepoint [1] 0 0
12 days
Secondary outcome [2] 0 0
Participant interest in device, based on Intrinsic Motivation Index questionnaire
Timepoint [2] 0 0
12 days
Secondary outcome [3] 0 0
Participant preference for TempTraq or CORE device
Timepoint [3] 0 0
14 days
Secondary outcome [4] 0 0
Comparability to intermittent ear thermometer data
Timepoint [4] 0 0
14 days
Secondary outcome [5] 0 0
Time between fever identification
Timepoint [5] 0 0
14 days
Secondary outcome [6] 0 0
Rates of skin irritation or infection
Timepoint [6] 0 0
14 days
Secondary outcome [7] 0 0
Participant age in years
Timepoint [7] 0 0
14 days
Secondary outcome [8] 0 0
Participant ethnicity
Timepoint [8] 0 0
14 days
Secondary outcome [9] 0 0
Participant diagnosis
Timepoint [9] 0 0
14 days
Secondary outcome [10] 0 0
Participant body mass index
Timepoint [10] 0 0
14 days
Secondary outcome [11] 0 0
Haematological treatment that participant is undergoing during study period
Timepoint [11] 0 0
14 days

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.
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Malaghan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05203809
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05203809