The Immersive Experience of Virtual Reality During Chemotherapy in Patients With Early Breast and Gynecological Cancers: the Patient's Dream Study

Study Overview
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Brief Summary
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Patient's dream study is a two-arm randomized controlled trial that will be conducted at Regina Elena National Cancer Institute, IRCCS (Rome), from April 2019 to January 2020. Before starting the first course of chemotherapy, patients will be randomly divided to receive the VRE (VRE arm) as distraction therapy, or to entertain themselves with conventional means such as listening to music, watching a mobile program, reading newspapers, books, magazines or also doing nothing, according to the patient's preferences and for the entire duration of administration of the first CT cycle (control arm). A clinical team composed of three oncologists, three psychologists, one nurse and one expert VR operator will support the patients involved in the study. The primary aims were the assessment of psychological distress, anxiety and quality of life between the two study arms. Secondary endpoints were the perceived time during the first course of CT and the acute and late toxicity. The study will conduct in accordance with the ethical standards as laid down in the Declaration of Helsinki and its later amendments and within the protocol approved by the Central Ethics Committee (Trial registration number: RS 1105/18). A written informed consent will obtain from all participants included in the study.

Official Title
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The Immersive Experience of Virtual Reality During Chemotherapy in Patients With Early Breast and Gynecological Cancers: the Patient's Dream Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: 3 Virtual Reality headset (VR Headset),


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria diagnosis of breast or ovarian cancer confirmed histologically, from I to III stage; surgery as first therapeutic approach (in case of ovarian cancer, patients with minimal residual disease after surgery will be also included) first cycle of adjuvant CT, with or without a biological treatment according to the specific cancer (regimens including anthracyclines/taxanes, anthracyclines/cyclophosphamide, carboplatinum/taxane combined or not with trastuzumab for breast cancer, carboplatin/paclitaxel combined or not with bevacizumab for ovarian cancer); aged ≥ 18 years; performance status (ECOG) 0-2; life expectancy > 12 months; ability to understand and sign the informed consent. Exclusion Criteria: presenting prior history of seizures; disorders of the mood; previous history of alcohol and/or drug addiction; disorder of vision and eyes; history of psychiatric pathologies.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: virtual reality<br>In The VRE arm, patients will use Virtual Reality headset (VR Headset), containing a selection of audiovisual productions made with 360 degrees technology and selected on the basis of content, plot and production dynamics. During the entire experience, an operator dedicated to patient care will be present to allow the most possible comfortable experience. | Device: 3 Virtual Reality headset (VR Headset),<br>* The VRE will administer through the use of 3 Virtual Reality headset (VR Headset), containing a selection of audiovisual productions made with 360 degrees technology and selected on the basis of content, plot and production dynamics.<br>|
| Active Comparator: control arm<br>In control arm, patients will entertain themselves with conventional means such as listening to music, watching a mobile program, reading newspapers, books, magazines or also doing nothing, according to the patient's preferences | Device: 3 Virtual Reality headset (VR Headset),<br>* The VRE will administer through the use of 3 Virtual Reality headset (VR Headset), containing a selection of audiovisual productions made with 360 degrees technology and selected on the basis of content, plot and production dynamics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of Distress | Distress is evaluate with HAds questionnaire | Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days | 
| evaluation of Quality of life | Quality of life is evaluate with QLQ-C30- BR23 | Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Incidence of treatment-emergent adverse events | this incidence in evaluate and classified with the Common Terminology Criteria for Adverse Events (CTCAE 5.0) | Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days | 
| Evaluation of Patients Report Outcomes | This outcomes is evaluated with PROs | Questionnaire is administered during three times: at baseline, after the somministration of the first cycle of chemotherapy and after 21 days, before the start of the second cycle. Each cycle in 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, virtual reality, supportive care