OSMS position management
DevicePatient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT)
Other names: VisionRT
NCT Number: NCT06257121
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT)
Other names: VisionRT
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.
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
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.
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.
Time frame: Once - at treatment planning, on average 2 weeks after baseline
Setup consistency between consecutive treatment planning scans
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)
Time frame: Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
Daily total fraction time as recorded
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
Contact information is provided by the study sponsor or research team.
Marie-Eve Pelland, Ph.D.
CONTACT
514-890-8000 ext. 28133
Mom Phat, RN
CONTACT
514-890-8000 ext. 11171
Centre hospitalier de l'Université de Montréal (CHUM)
Other
A Pilot Study to Assess the Use of Surface-guided Radiotherapy in Head and Neck Cancer Patients Who Suffer From Anxiety
Acronym: CRISP
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