Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients

NCT ID: NCT06257121

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-02-01

Brief 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.

Conditions

Head and Neck Cancer; Claustrophobia; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OSMS position management

Intervention Type: DEVICE

Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT)

Interventions

OSMS position management

Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT)

Intervention Type: DEVICE

Other Intervention Names

VisionRT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Marie-Eve Pelland

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie-Eve Pelland, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHUM

Central Contacts

Mom Phat, RN

Role: CONTACT

mom.phat.chum@ssss.gouv.qc.ca

514-890-8000 ext. 11171

Marie-Eve Pelland, Ph.D.

Role: CONTACT

marie-eve.pelland.chum@ssss.gouv.qc.ca

514-890-8000 ext. 28133

Other Identifiers

2024-11940

Identifier Type: -

Identifier Source: org_study_id