Head and Neck CancerCRISPNCT06257121
Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients
A study testing OSMS position management in people with Head and Neck Cancer and Claustrophobia, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Claustrophobia, Anxiety
- What is being tested?
- OSMS position management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Study to Assess the Use of Surface-guided Radiotherapy in Head and Neck Cancer Patients Who Suffer From Anxiety
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.
Read more
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.
- Conditions
- Head and Neck Cancer, Claustrophobia, Anxiety
- Being tested
- OSMS position management
- Keywords
- Head and neck cancer, Anxiety, Claustrophobia, Surface-guided imagery, Radiation therapy
- Medical subject headings
- Head and Neck Neoplasms, Claustrophobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSMS position managementDevice
Also called VisionRT
Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT)
| Study group | Role | What they receive |
|---|---|---|
| SGRT | Experimental | Patient position will be managed by optical surface management system (OSMS). Equipment for this procedure includes an IMRT board, a long head cushion (with transparent Timo, moldcare, and shim), anatomical markers the cushion (shoulders, under the chin, etc.), a kneefix and arm plates. Every day, prior to treatment, there will be (1) A lateral kilo voltage (kV) image for jaw positioning and (2) a CBCT with standard match (3D column then 3D GTV/PTV). During treatment, patients will undergo real-time monitoring with the VisionRT system (SGRT). A second CBCT will de carried mid-treatment (after the 2nd of 3 arcs) and patient's position will be adjusted if deemed necessary. Receives: Device: OSMS position management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: weekly from baseline to last week of treatment
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
Measured: weekly from baseline to end of radiation therapy, an average of 7 weeks
Claustrophobia
Claustrophobia Questionnaire (CLQ), includes two subscales of 14 and 12 items, total scores range from 0 to 104. Higher score indicates worse outcome.
Measured: weekly from baseline to end of radiation therapy, an average of 7 weeks
Secondary outcomes (5)
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.
Measured: weekly from baseline to end of radiation therapy, an average of 7 weeks
Setup consistency
Setup consistency between consecutive treatment planning scans
Measured: Once - at treatment planning, on average 2 weeks after baseline
Intrafraction setup consistency
Intrafraction setup consistency as reported by the surface guidance system (total amplitude \& max deviation over time)
Measured: Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
Fraction time
Daily total fraction time as recorded
Measured: Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
Skin toxicity
Skin toxicity grade assessed by treating rdio-oncologist at weekly follow-up
Measured: weekly from baseline to end of radiation therapy, an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Oct 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Eve Pelland, Ph.D., Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257121
- Sponsor's protocol ID
- 2024-11940
- Acronym
- CRISP
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Use of Surface-guided Radiotherapy in Head and Neck Cancer Patients Who Suffer From Anxiety
- ClinicalTrials.gov ID
- NCT06257121
- Acronym / sponsor ID
- CRISP / 2024-11940
- Conditions
- Head and Neck Cancer, Claustrophobia, Anxiety
- Keywords
- Head and neck cancer, Anxiety, Claustrophobia, Surface-guided imagery, Radiation therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGRT | Experimental | Device: OSMS position managementPatient position will be managed by optical surface management system (OSMS). Equipment for this procedure includes an IMRT board, a long head cushion (with transparent Timo, moldcare, and shim), anatomical markers the cushion (shoulders, under the chin, etc.), a kneefix and arm plates. Every day, prior to treatment, there will be (1) A lateral kilo voltage (kV) image for jaw positioning and (2) a CBCT with standard match (3D column then 3D GTV/PTV). During treatment, patients will undergo real-time monitoring with the VisionRT system (SGRT). A second CBCT will de carried mid-treatment (after the 2nd of 3 arcs) and patient's position will be adjusted if deemed necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSMS position managementAlso: VisionRTPatient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT) | Device | SGRT |
Primary outcome
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.
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
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.
5 secondary outcomes
Well-being
Time frame: weekly from baseline to end of radiation therapy, an average of 7 weeks
Setup consistency
Time frame: Once - at treatment planning, on average 2 weeks after baseline
Intrafraction setup consistency
Time frame: Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
Fraction time
Time frame: Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
Skin toxicity
Time frame: weekly from baseline to end of radiation therapy, an average of 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Eve Pelland, Ph.D. principal investigator
CHUM
Questions about this trial
What is this clinical trial studying?
A study testing OSMS position management in people with Head and Neck Cancer and Claustrophobia, run by Centre hospitalier de l'Université de Montréal (CHUM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mom Phat, RN (514-890-8000 ext. 11171, mom.phat.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety questionnaire (time frame: weekly from baseline to last week of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.