Clinical trial NCT06257121: Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients
Official title: A Pilot Study to Assess the Use of Surface-guided Radiotherapy in Head and Neck Cancer Patients Who Suffer From Anxiety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Claustrophobia
Anxiety
Keywords: Head and neck cancer
Anxiety
Claustrophobia
Surface-guided imagery
Radiation therapy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Anxiety questionnaire
timeFrame: weekly from baseline to last week of treatment
measure: Anxiety behavior
timeFrame: weekly from baseline to end of radiation therapy, an average of 7 weeks
measure: Claustrophobia
timeFrame: weekly from baseline to end of radiation therapy, an average of 7 weeks
Secondary outcomes:
measure: Well-being
timeFrame: weekly from baseline to end of radiation therapy, an average of 7 weeks
measure: Setup consistency
timeFrame: Once - at treatment planning, on average 2 weeks after baseline
measure: Intrafraction setup consistency
timeFrame: Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
measure: Fraction time
timeFrame: Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
measure: Skin toxicity
timeFrame: weekly from baseline to end of radiation therapy, an average of 7 weeks
Other outcomes:
Locations:
Study officials:
affiliation: CHUM
name: Marie-Eve Pelland, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: