Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients (CRISP)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer; Anxiety; Claustrophobia
• Intervention / Treatment: Device: OSMS position management

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mom Phat, RN; Phone Number: 11171 514-890-8000; Email: mom.phat.chum@ssss.gouv.qc.ca
• Study Contact Backup: Name: Marie-Eve Pelland, Ph.D.; Phone Number: 28133 514-890-8000; Email: marie-eve.pelland.chum@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 (e.g., Parkinson's disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SGRT; 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.

Device: OSMS position management; Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT); Other Names: VisionRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Marie-Eve Pelland, Ph.D., CHUM

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Radiation therapy; Head and neck cancer; Claustrophobia; Surface-guided imagery
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: 2024-11940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No