Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257121
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-12-19
Brief Title:
Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRISP
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 masks 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 anxiousclaustrophobic 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 claustrophobiaanxiety
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 claustrophobicanxious 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 ie 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 ie a Phase III clinical trial comparing the use of SGRT with the use of a thermoplastic immobilization mask for anxious patients
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 claustrophobiaanxiety
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 claustrophobicanxious 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 ie 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 ie a Phase III clinical trial comparing the use of SGRT with the use of a thermoplastic immobilization mask for anxious patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None