Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

Background: Radiotherapy is a mainstay of treatment for ENT cancers, and its indication is frequent. Patients are positioned and immobilized using a thermoplastic mask, which is attached to the treatment table for the duration of each daily treatment. The mask's purpose is to prevent patient movement and ensure reproducible positioning. The advantages of using thermoplastic masks come at a cost for many patients. It is well established that mask fixation and mask anxiety are major concerns for patients, adversely affecting their quality of life and hindering treatment compliance. Surface-guided radiotherapy (SGRT) enables patients to be positioned and their movements monitored in real time during treatment. This technique has become more widely available in recent years, and is attractive because it does not involve ionizing radiation. However, although preliminary data have suggested a potential reduction in anxiety, this technique has not been evaluated for ENT RT in anxious/claustrophobic patients who cannot tolerate immobilization masks.

Objective: Investigators propose a pilot study to evaluate the feasibility and tolerability of using SGRT to manage position for patients with ENT cancer who report claustrophobia/anxiety.

Methodology: 15 participants will be recruited by the treating radiation oncologist from among patients scheduled to undergo radiation therapy at CHUM for their ENT cancer and identifying as claustrophobic/anxious. Participants who consent will be scheduled to undergo their radiotherapy using SGRT. Patients will be systematically treated with Volumetric Modulated Arc Therapy (VMAT) using SGRT on the linear accelerator with the Optical Surface Management System (OSMS) for the duration of the radiotherapy.

Measures: Patients' anxiety will be assessed using the GAD-7 and the CLQ throughout the treatment process. The feasibility and accuracy of radiotherapy treatment will be assessed using planning and daily pre-treatment examinations. In addition, skin toxicity will be assessed weekly.

Analyses: 1) Descriptive analyses, i.e. frequencies for categorical variables and means and standard deviations for continuous variables. 2) Estimation of confidence intervals.

Anticipated outcomes: Completion of this pilot project will enable investigators to plan and refine the methodological and organizational aspects for a large-scale study, i.e., a Phase III clinical trial comparing the use of SGRT with the use of a thermoplastic immobilization mask for anxious patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eighteen years of age or older

Able to fluently speak, read and write French or English

Histologically confirmed head and neck cancer

Patients treated with radiotherapy as primary treatment

Disqualifiers

Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study

Patients who cannot stay still during fraction because of a disorder or physical condition (e.g., Parkinson's disease)

Trial design

Design model

Single group

Treatments tested in this trial

  • OSMS position management

    Device

    Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT)

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: SGRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anxiety questionnaire

Generalized Anxiety Disorder Questionnaire (GAD-7), GAD-7 total score for the seven items ranges from 0 to 21. Higher score indicates worse outcome.

Time frame
weekly from baseline to last week of treatment
2

Anxiety behavior

Behavioral assessments of anxiety: (a) use of psychoactive (anxiolytic) medication; (b) use of psychological interventions / strategies (exposure therapy, relaxation / meditation, etc.); (c) use of music in treatment room; (d) need for vocal reassurance by technologists during scan/MRI; (e) exam interruptions

Time frame
weekly from baseline to end of radiation therapy, an average of 7 weeks
3

Claustrophobia

Claustrophobia Questionnaire (CLQ), includes two subscales of 14 and 12 items, total scores range from 0 to 104. Higher score indicates worse outcome.

Time frame
weekly from baseline to end of radiation therapy, an average of 7 weeks

Secondary outcomes

1

Well-being

Functional Assessment of Cancer Therapy scale (FACT-G7). Total score for seven items ranges from 0 to 28. Higher score indicates better outcome.

Time frame
weekly from baseline to end of radiation therapy, an average of 7 weeks
2

Setup consistency

Setup consistency between consecutive treatment planning scans

Time frame
Once - at treatment planning, on average 2 weeks after baseline
3

Intrafraction setup consistency

Intrafraction setup consistency as reported by the surface guidance system (total amplitude \& max deviation over time)

Time frame
Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
4

Fraction time

Daily total fraction time as recorded

Time frame
Daily from first to last radiotherapy treatment fraction, an average 7 weeks.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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