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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04266223




Registration number
NCT04266223
Ethics application status
Date submitted
9/12/2019
Date registered
12/02/2020

Titles & IDs
Public title
Surface Monitoring Technology to Remove The Mask - Stage 1
Scientific title
Surface Monitoring Technology to Remove The Mask - Stage 1
Secondary ID [1] 0 0
U1111-1248-2457
Secondary ID [2] 0 0
SMART
Universal Trial Number (UTN)
Trial acronym
SMART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Radiation Therapy Complication 0 0
Anxiety 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Mask-free surface monitoring

Experimental: Mask-free surface monitoring - Lay in treatment position for 20 minutes with surface monitoring technology activated


Treatment: Devices: Mask-free surface monitoring
Mask-free headrest and couch for patient positioning for radiation therapy combined with a surface monitoring system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continuous acquisition of position and motion data of anatomical structures by the surface monitoring system
Timepoint [1] 0 0
20 minutes
Primary outcome [2] 0 0
Patient acceptance of the surface monitoring system
Timepoint [2] 0 0
10 minutes
Secondary outcome [1] 0 0
Patient experience
Timepoint [1] 0 0
45 minutes
Secondary outcome [2] 0 0
Radiation therapists' experience
Timepoint [2] 0 0
5 minutes
Secondary outcome [3] 0 0
Absolute Residual Motion of cranial and upper torso anatomy
Timepoint [3] 0 0
20 minutes
Secondary outcome [4] 0 0
Relative Residual Motion of cranial and upper torso anatomy
Timepoint [4] 0 0
20 minutes
Secondary outcome [5] 0 0
Change in number of detectable anatomical landmarks after patient residual motion
Timepoint [5] 0 0
20 minutes
Secondary outcome [6] 0 0
Photograph record of physical characteristics of face and hair that may affect detection of anatomical landmarks by the surface monitoring system
Timepoint [6] 0 0
5 seconds
Secondary outcome [7] 0 0
Effect of change in participants' weight (kg) from pre_RT to late RT on absolute residual motion of cranial and upper torso anatomy
Timepoint [7] 0 0
4 to 6 weeks
Secondary outcome [8] 0 0
Effect of change in participants' weight (kg) from pre_RT to late RT on relative residual motion of cranial and upper torso anatomy
Timepoint [8] 0 0
4 to 6 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

* A diagnosis of head and neck cancer, any stage
* = 18 years of age
* ECOG performance status 0-2
* Receiving radiation therapy for HNC with a thermoplastic immobilisation mask
* Any other prior therapy allowed
* Willing and able to comply with all study requirements
* Must be able to read and complete questionnaires in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* People with cognitive impairment which would preclude them from providing informed consent
* People who are unable to speak and read English and for whom obtaining consent would be difficult.

Withdrawal Criteria

* Participants may withdraw from the study at any time before, during or after participation, and do not have to provide a reason. They may do so by advising any member of the study team, research office or their treating team, by completing the withdrawal of consent form, verbally or in writing.
* Participants may be withdrawn from the study by the principal investigator, treating physician or attending clinician if they perceive the participant is experiencing or will likely experience physical or mental harm
* No additional study data will be collected for a participant after they withdraw from the study
* Withdrawing participants' data will be used unless the participant specifies they no longer give permission for the data to be stored or used, however, their data will not be removed from any analysis or publication that has already occurred, or from study databases once it has been de-identified
* Participant will be replaced if they withdraw or are withdrawn from the study prior to starting the second couch session. This will be done by recruitment of an additional participant.
* If a couch session is ended by the researcher or participant for reasons unrelated to the study (e.g. not related to equipment failure or participant non-acceptance), the session may be rescheduled, or participant replaced.
* Reasons for withdrawal will be reported in any outcome publications.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 0 0
2049 - Blacktown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Western Sydney Local Health District
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Purmina Sundaresan, Dr
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Keall, Prof
Address 0 0
Country 0 0
Phone 0 0
+61 2 8627 1133
Fax 0 0
Email 0 0
paul.keall@sydney.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable individual participant data (IPD) may be shared with researchers for further scientific research. Facial images/photos identifying participants will not be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
Not before the study completion. For not more than 15 years after study completion, at which time the data sharing plan will be revised.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04266223