Anxiety Clinical Trial
— SMARTOfficial title:
Surface Monitoring Technology to Remove The Mask - Stage 1
A pilot-stage device feasibility study investigating a mask-free motion-monitoring patient immobilisation system for use during radiation therapy treatment of head and neck cancer (HNC). This mask-free system combines the standard radiation therapy (RT) head rest to help the patient remain still with a surface guidance detection system that uses sensors to detect and track patient movement. Patients who will have RT treatment for head and neck cancer involving an immobilisation mask will be asked to lie on the treatment couch for the normal treatment fraction time while the surface monitoring system is activated. We will then assess: i) The level of acceptance of the system by HNC patients currently being treated with RT using an immobilisation mask, and ii) The ability of the surface guidance system to monitor movement of the patients
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 - Participants may be withdrawn from the study by the principal investigator, treating physician or attending clinician if they perceive the participant is experiencing or will likely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. |
Country | Name | City | State |
---|---|---|---|
Australia | Blacktown Hospital | Blacktown | New South Wales |
Lead Sponsor | Collaborator |
---|---|
University of Sydney | Western Sydney Local Health District |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Continuous acquisition of position and motion data of anatomical structures by the surface monitoring system | Technical feasibility of surface-monitoring system in =90% of consumers - operates continuously throughout the session and provides information on the position and motion of the cranium, mandible and shoulders without obvious erroneous results or faults | 20 minutes | |
Primary | Patient acceptance of the surface monitoring system | Patients complete the session AND give a mean score of 4 or more for both comfort and acceptability on a Likert scale of 1-7, where 1 = 'Very Strongly Disagree' and 7 = 'Very Strongly Agree' | 10 minutes | |
Secondary | Patient experience | Qualitative semi-structured interview of patient experience of interacting with the surface monitoring system and how that compared with the experience of the immobilisation mask during their radiation therapy treatment. | 45 minutes | |
Secondary | Radiation therapists' experience | Questionnaire of radiation therapist's experience scored according to a Likert scale of 1-5 where 1 = 'Strongly Disagree' and 5 = 'Strongly Agree' | 5 minutes | |
Secondary | Absolute Residual Motion of cranial and upper torso anatomy | Distance and direction of, and correlation between, motion of the cranial and upper torso anatomy relative to the fixed isocentre | 20 minutes | |
Secondary | Relative Residual Motion of cranial and upper torso anatomy | Distance and direction of, and correlation between, motion of the cranial and upper torso anatomy relative to first image taken | 20 minutes | |
Secondary | Change in number of detectable anatomical landmarks after patient residual motion | Change in number of detection of points in the point cloud in response to residual motion of anatomical landmarks over 20 minutes of continuous data acquisition | 20 minutes | |
Secondary | Photograph record of physical characteristics of face and hair that may affect detection of anatomical landmarks by the surface monitoring system | A photograph taken by the system camera showing physical characteristics of face and hair (e.g. shape, tone, location, size) | 5 seconds | |
Secondary | Effect of change in participants' weight (kg) from pre_RT to late RT on absolute residual motion of cranial and upper torso anatomy | The effect of change in weight (kg) from pre-RT to late RT on Outcome 5 | 4 to 6 weeks | |
Secondary | Effect of change in participants' weight (kg) from pre_RT to late RT on relative residual motion of cranial and upper torso anatomy | The effect of change in weight (kg) from pre-RT to late RT on Outcome 6 | 4 to 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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