Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSMS position management | Device | Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | weekly from baseline to end of radiation therapy, an average of 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | weekly from baseline to end of radiation therapy, an average of 7 weeks |
| Setup consistency |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mom Phat, RN | Contact | 514-890-8000 | 11171 | mom.phat.chum@ssss.gouv.qc.ca |
| Marie-Eve Pelland, Ph.D. | Contact | 514-890-8000 | 28133 | marie-eve.pelland.chum@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Eve Pelland, Ph.D. | CHUM | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000098452 | Claustrophobia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010698 | Phobic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Setup consistency between consecutive treatment planning scans
| 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) | Daily from first to last radiotherapy treatment fraction, an average 7 weeks. |
| Fraction time | Daily total fraction time as recorded | 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 | weekly from baseline to end of radiation therapy, an average of 7 weeks |