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NCT Number: NCT06257121

Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Identified as having moderate mask anxiety / claustrophobia (i.e. a score of 10 or more on the Generalized Anxiety Disorder 7 item (GAD-7) questionnaire and / or a score of 28 or more on the Claustrophobia questionnaire (CLQ) suffocation subscale and / a score of 24 or more on the CLQ restriction subscale
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0-2
  • Able to understand and sign consent form
  • Patients must be willing to comply with treatment plan and other study procedures

Exclusion criteria

  • 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)

Treatment and study plan

OSMS position management

Device

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

Other names: VisionRT

Primary outcomes

  1. Anxiety questionnaire

    Time frame: weekly from baseline to last week of treatment

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

  2. Anxiety behavior

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

    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

  3. Claustrophobia

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

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

Secondary outcomes

  1. Well-being

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

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

  2. Setup consistency

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

    Setup consistency between consecutive treatment planning scans

  3. Intrafraction setup consistency

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

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

  4. Fraction time

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

    Daily total fraction time as recorded

  5. Skin toxicity

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

    Skin toxicity grade assessed by treating rdio-oncologist at weekly follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Eve Pelland, Ph.D.

CONTACT

[email protected]

514-890-8000 ext. 28133

Mom Phat, RN

CONTACT

[email protected]

514-890-8000 ext. 11171

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

A Pilot Study to Assess the Use of Surface-guided Radiotherapy in Head and Neck Cancer Patients Who Suffer From Anxiety

Acronym: CRISP

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 13, 2024
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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