Breast Cancer Clinical Trial
— VRtuose1Official title:
VRtuose (Virtual RealiTy and mUsic in the Oncology SEtting) : A Single-centre Feasibility Study Evaluating a Strategy Combining Virtual Reality and Music to Improve Quality of Life in Breast Cancer Patients Undergoing Chemotherapy
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed diagnosis of breast cancer; - Any disease stage; - Patient must be receiving (i.e., with at least 4 remaining cures) or about to start palliative or curative neoadjuvant or adjuvant chemotherapy for their breast cancer at Centre Léon Bérard; - Willingness and ability to comply with the study requirements; - Patient must be covered by a medical insurance; - Patient must understand, speak, read and write French. Exclusion Criteria: - History of condition contraindicating the use of virtual reality (e.g., epilepsy, severe motion sickness); - Brain metastases; - Any medical or psychosocial condition that would compromise the patient's compliance to the study procedures or would likely interfere with the completion of Patient-Reported Outcomes; - Patients under tutorship or curatorship; - Patients already included in another clinical trial ongoing at Centre Léon Bérard. |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon |
Lead Sponsor | Collaborator |
---|---|
International Agency for Research on Cancer | Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acceptance rate to fill in questionnaires measuring clinical outcomes | Questionnaires measuring clinical outcomes will include the EORTC Quality of Life Group Core Questionnaire (EORTC QLQ-C30), the State Anxiety Inventory (short form), a visual analogue scale to measure pain, and the Simulator Sickness Questionnaire. | Through study completion, an average of 8 months. | |
Other | Time taken to fill in questionnaires measuring clinical outcomes | Questionnaires measuring clinical outcomes will include the EORTC Quality of Life Group Core Questionnaire (EORTC QLQ-C30), the State Anxiety Inventory (short form), a visual analogue scale to measure pain, and the Simulator Sickness Questionnaire. | Through study completion, an average of 8 months. | |
Other | Completeness of questionnaires measuring clinical outcomes | Questionnaires measuring clinical outcomes will include the EORTC Quality of Life Group Core Questionnaire (EORTC QLQ-C30), the State Anxiety Inventory (short form), a visual analogue scale to measure pain, and the Simulator Sickness Questionnaire. | Through study completion, an average of 8 months. | |
Primary | Patients' acceptance rate regarding the use of the distraction strategy. | Average of the number of times the strategy is used by each patient out of the number of chemotherapy cures it is offered to each patient. | Through study completion, an average of 8 months. | |
Secondary | Accessibility of the strategy | Percentage of chemotherapy sessions when strategy administrators offer patients to use the strategy. | Through study completion, an average of 8 months. | |
Secondary | Duration of use of the strategy by patients | Time elapsed in between start of the first video and end of the last video watched by the participant. | Through study completion, an average of 8 months. | |
Secondary | Type of video content chosen by participants | Measured using a questionnaire | Through study completion, an average of 8 months. | |
Secondary | Type of music content chosen by participants | Measured using a questionnaire | Through study completion, an average of 8 months. | |
Secondary | Patients' perception of factors limiting the use of the strategy | Measured using a questionnaire | Measured at first use of the strategy and at the end of the study follow-up | |
Secondary | Healthcare providers' perception of factors limiting the use of the strategy | Measured using a questionnaire | One and four months after the start of the study | |
Secondary | Workload for strategy administrators | Total time taken by strategy administrators to set up the strategy, explain its functioning to participants and clean it. | Through study completion, an average of 8 months. | |
Secondary | Strategy administrators ability to use the strategy | Measured using a questionnaire | Through study completion, an average of 8 months. | |
Secondary | Patients' satisfaction regarding the use of the strategy | Measured using a questionnaire | Measured at first use of the strategy and at the end of the study follow-up | |
Secondary | Healthcare providers' satisfaction regarding the strategy | Measured using a questionnaire | One and four months after the start of the study | |
Secondary | Prevalence of adverse events related to the use of the strategy | Percentage of times when use of the strategy is stopped early due to adverse events occurring during its use. | Through study completion, an average of 8 months. | |
Secondary | Type of adverse events related to the use of the strategy | Measured using the Simulator Sickness Questionnaire | Through study completion, an average of 8 months. | |
Secondary | Severity of adverse events related to the use of the strategy | Measured using the Simulator Sickness Questionnaire | Through study completion, an average of 8 months. |
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