protocolSection identificationModule nctId: NCT06305117, orgStudyIdInfo id: PP202304-37-1, secondaryIdInfos id: 101227, type: OTHER_GRANT, domain: Association Ruban Rose, briefTitle: Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1, acronym: VRtuose1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: International Agency for Research on Cancer, class: OTHER, collaborators name: Centre Leon Berard, descriptionModule briefSummary: The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Distraction strategy, outcomesModule primaryOutcomes measure: Patients' acceptance rate regarding the use of the distraction strategy., secondaryOutcomes measure: Accessibility of the strategy, secondaryOutcomes measure: Duration of use of the strategy by patients, secondaryOutcomes measure: Type of video content chosen by participants, secondaryOutcomes measure: Type of music content chosen by participants, secondaryOutcomes measure: Patients' perception of factors limiting the use of the strategy, secondaryOutcomes measure: Healthcare providers' perception of factors limiting the use of the strategy, secondaryOutcomes measure: Workload for strategy administrators, secondaryOutcomes measure: Strategy administrators ability to use the strategy, secondaryOutcomes measure: Patients' satisfaction regarding the use of the strategy, secondaryOutcomes measure: Healthcare providers' satisfaction regarding the strategy, secondaryOutcomes measure: Prevalence of adverse events related to the use of the strategy, secondaryOutcomes measure: Type of adverse events related to the use of the strategy, secondaryOutcomes measure: Severity of adverse events related to the use of the strategy, otherOutcomes measure: Acceptance rate to fill in questionnaires measuring clinical outcomes, otherOutcomes measure: Time taken to fill in questionnaires measuring clinical outcomes, otherOutcomes measure: Completeness of questionnaires measuring clinical outcomes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Léon Bérard, city: Lyon, country: France, contacts name: Olivier Trédan, MD, role: CONTACT, email: olivier.tredan@lyon.unicancer.fr, contacts name: Olivier Trédan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False