Optimising Patient Experience in Head and Neck Radiotherapy

Trial Title: Optimising Patient Experience in Head and Neck Radiotherapy

NCT ID: NCT06327139

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Conditions: Keywords:
Radiation Therapy
Set-up Accuracy
Faceless Mask
Immobilisation
Quality of Life

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. A faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring, a faceless five point mask in conjunction with intra fraction surface guided monitoring and a conventional closed face five point mask without the use of intra fraction surface guided monitoring are being investigated in this study. The set-up accuracy will be based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Conventional 5 point closed face immobilisation mask.
Description: The conventional closed face mask is a standard of care immobilization device for head and neck cancer patients which covers and immobilizes the entire anterior portion of the patients head, neck and shoulders using a semi rigid thermoplastic material.
Arm group label: Arm One: Conventional 5 point closed face immobilisation mask.

Intervention type: Device
Intervention name: 5 point open face immobilization mask
Description: The 5 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the level of their clavicle.
Arm group label: Arm Two: 5 point open face immobilization mask

Other name: The open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest.

Intervention type: Device
Intervention name: 3 point open face immobilization mask
Description: The 3 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the below the patients chin. The three point mask does not cover the patients shoulders and does not extend inferiorly to the level of the clavicle.
Arm group label: Arm Three: 3 point open face immobilization mask

Summary: This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy. Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment.

Detailed description: This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The two types of immobilization under investigation consist of a faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring and a faceless five point mask in conjunction with intra fraction surface guided monitoring. The standard of care immobilization consists of a conventional closed face five point mask without the use of intra fraction surface guided monitoring. . The primary aim of this study is to determine the set-up accuracy of the two types of faceless mask compared with the conventional closed face mask. The set-up accuracy will be measured based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction. This will be measured in millimeters on the daily CBCT. The secondary aim of this study is to determine the level of distress associated with each type of immobilization device. A total of 198 evaluable patients will be required for the study. The sample size was calculated based on power calculations to detect clinically significant differences in setup accuracy and patient experience across the three arms. The enrollment period is expected to be 1 year. Translational corrections will be measured prior to each fraction of radiation therapy delivered and a minimum of 30 fractions must be delivered in order for a patient to be considered evaluable on trial. The open faced masks will be considered equivalent to the standard of care closed faced mask in terms of set-up accuracy if the difference in translational corrections across the three groups does not indicate a necessity for an increase in the planning target volume for patients planned for radiation therapy treatment using an open faced mask. Level's of distress will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12). The open faced masks will be considered equivalent to the standard of care closed faced mask the difference in level's of distress between groups does not meet the significance level 0.5.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. All radical H&N patients receiving 30-35 fractions of Radiotherapy 2. Written informed consent obtained prior to any study-specific procedures 3. ≥18 years of age Exclusion Criteria: 1) Patient who from the outset who would not tolerate or would be unable to proceed with treatment if placed in a closed mask, at the discretion of either the patient or the clinician.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: St. Luke's Radiation Oncology Network

Address:
City: Dublin
Zip: D06 HH36
Country: Ireland

Status: Recruiting

Contact:
Last name: Roisin O Maolalai, BSc

Phone: 0035314065458
Email: Roisin.OMaolalai@slh.ie

Contact backup:
Last name: Emma Noone, BSc MA

Phone: 003534065467
Email: Emma.Noone@slh.ie

Investigator:
Last name: Sinead Brennan, FFR RCSI
Email: Principal Investigator

Start date: January 2, 2024

Completion date: July 2025

Lead sponsor:
Agency: Irish Research Radiation Oncology Group
Agency class: Other

Source: Irish Research Radiation Oncology Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06327139