Surface Monitoring Technology to Remove The Mask - Stage 1

NCT04266223 | Recruiting

• 2 other identifiers: SMARTU1111-1248-2457
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer; Radiation Therapy Complication; Anxiety

Keywords

Radiation Therapy; Mask; Anxiety; Motion sickness; Claustrophobia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Patient experience

  45 minutes

• Radiation therapists' experience

  5 minutes

• Absolute Residual Motion of cranial and upper torso anatomy

  20 minutes

• Relative Residual Motion of cranial and upper torso anatomy

  20 minutes

• Change in number of detectable anatomical landmarks after patient residual motion

  20 minutes

Study Arms (1)

Mask-free surface monitoring

EXPERIMENTAL

Lay in treatment position for 20 minutes with surface monitoring technology activated

Device: Mask-free surface monitoring

Interventions

Mask-free surface monitoring DEVICE

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

Mask-free surface monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead
• Western Sydney Local Health District: collaborator

Study Sites (1)

Blacktown Hospital

Blacktown, New South Wales, 2049, Australia

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Anxiety Disorders; Motion Sickness; Claustrophobia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders

Study Officials

• Purmina Sundaresan, Dr

  Western Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Keall, Prof

CONTACT

+61 2 8627 1133; paul.keall@sydney.edu.au

Shona Silvester

CONTACT

+61 2 8627 1185; shona.silvester@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a hypothesis-producing feasibility study that does not involve power calculations. The number of participants (20) was chosen to enable confidence in the primary outcome calculation.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: February 12, 2020
• Study Start: March 28, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 1, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Not before the study completion. For not more than 15 years after study completion, at which time the data sharing plan will be revised.

Locations

AU (1)