protocolSection identificationModule nctId: NCT06327139, orgStudyIdInfo id: CTRIAL 23-24, briefTitle: Optimising Patient Experience in Head and Neck Radiotherapy, acronym: OPEN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Irish Research Radiation Oncology Group, class: NETWORK, descriptionModule briefSummary: 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., conditionsModule conditions: Head and Neck Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 201, type: ESTIMATED, armsInterventionsModule interventions name: Conventional 5 point closed face immobilisation mask., interventions name: 5 point open face immobilization mask, interventions name: 3 point open face immobilization mask, outcomesModule primaryOutcomes measure: The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction., secondaryOutcomes measure: Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Luke's Radiation Oncology Network, status: RECRUITING, city: Dublin, zip: D06 HH36, country: Ireland, contacts name: Roisin O Maolalai, BSc, role: CONTACT, phone: 0035314065458, email: Roisin.OMaolalai@slh.ie, contacts name: Emma Noone, BSc MA, role: CONTACT, phone: 003534065467, email: Emma.Noone@slh.ie, contacts name: Sinead Brennan, FFR RCSI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False