Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients — CRISP  

Anxiety Clinical Trial

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

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Claustrophobia
• Head and Neck Cancer
• Head and Neck Neoplasms
• Phobic Disorders

• NCT number: NCT06257121
• Study type: Interventional
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Mom Phat, RN
• Phone: 514-890-8000
• Email: mom.phat.chum@ssss.gouv.qc.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Completion date: February 1, 2026