Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients

NCT06257121 | Not Yet Recruiting DMC

• 1 other identifier: 2024-11940
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Keywords

Head and neck cancer; Anxiety; Claustrophobia; Surface-guided imagery; Radiation therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Well-being

  weekly from baseline to end of radiation therapy, an average of 7 weeks

• Setup consistency

  Once - at treatment planning, on average 2 weeks after baseline

• Intrafraction setup consistency

  Daily from first to last radiotherapy treatment fraction, an average 7 weeks.

• Fraction time

  Daily from first to last radiotherapy treatment fraction, an average 7 weeks.

• Skin toxicity

  weekly from baseline to end of radiation therapy, an average of 7 weeks

Study Arms (1)

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.

Device: OSMS position management

Interventions

OSMS position management DEVICE

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

Also known as: VisionRT

SGRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Claustrophobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Phobic Disorders; Mental Disorders

Study Officials

• Marie-Eve Pelland, Ph.D.

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mom Phat, RN

CONTACT

514-890-8000; mom.phat.chum@ssss.gouv.qc.ca

Marie-Eve Pelland, Ph.D.

CONTACT

514-890-8000; marie-eve.pelland.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: February 13, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share