Health TrialsbyHealthPanel

Surface Monitoring Technology to Remove The Mask - Stage 1

ConditionsHead and Neck CancerRadiation Therapy ComplicationAnxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

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Participants may be withdrawn from the study by the principal investigator, treating physician or attending clinician if they perceive the participant is experiencing or will likely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

Trial design

Design model

Single group

Treatments tested in this trial

  • Mask-free surface monitoring

    Device

    Mask-free headrest and couch for patient positioning for radiation therapy combined with a surface monitoring system

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Mask-free surface monitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
20 minutes
2

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'

Time frame
10 minutes

Secondary outcomes

1

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.

Time frame
45 minutes
2

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'

Time frame
5 minutes
3

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

Time frame
20 minutes
4

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

Time frame
20 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sydney

Lead sponsor

Western Sydney Local Health District

Collaborator

Source ClinicalTrials.gov
Apply now