Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure
研究概览
简要总结
The aim of the REV clinical trial is to evaluate the impact of a virtual reality exposure to decrease patient anxiety before chemotherapy or an invasive act. If positive, the access to virtual reality exposure is aimed to be used as standard of care at Lyon's hospital to improve cancer patient well-being in a drug-free manner.
The majority of cancer patients lives with high level of anxiety as soon as diagnosed. This level anxiety is particularly high before invasive acts but also before chemotherapy by side effects anticipation.
Hypnosis is a highly interesting drug-free approach to decrease patient's anxiety. It however requires on site specialists to be available whenever needed.
Virtual reality provides a distractive environment enabled to shift patient focus. It can support a switch of patient mindset by providing positive emotions.
Since 5 years, this disruptive technology is being more and more used as medical support thanks to a new generation of headsets enabling improved performance at cheaper prices.
Many publications have now demonstrated the positive impact of virtual reality to take in charge patients' pain or pre-operational anxiety.
详细描述
The primary objective of the REV study is to demonstrate the difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y) before patients undergo an oncological procedure (invasive act or chemotherapy (C1D1).
The investigator's REV study aims to recruit 66 patients among three cohorts (22 patients per cohort) in 12 months.
- Breast cancer cohort (patient receiving an adjuvant or neoadjuvant chemotherapy with doxorubicin and cyclophosphamide)
- Head or neck cancer cohort (patient treated by concomitant radiochemotherapy)
- Cancer patient for which an invasive act inducing anxiety is planned (lumbar puncture, ascites puncture, thoracocentesis, myelogram, bone marrow biopsy, urinary catheterization, ..)
The REV study aims to impact Lyon's hospital patients' quality of life and well-being by decreasing their anxiety level during oncological treatments thanks to innovative supportive cares.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
44 patients for the cohort " chemotherapy " and 22 patients for the cohort " invasive act ".
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all patients:
- •Patient Study Information and written informed consent
- •Social Security Affiliation
- •For breast cancer cohort :
- •Adult patient (>18 years)
- •Histological or cytological proven breast cancer
- •Eligible to an adjuvant or neo-adjuvant IV chemotherapy given every 2 to 3 weeks (with protocol doxorubicin- cyclophosphamide, docetaxel-cyclophosmadide, docetaxel-cyclophosphamide-trastuzumab, docetaxel, carboplatine, trastuzumab, epirubicin-cyclophosphamide, etc)
- •Therapeutic strategy validated in multidisciplinary meeting
- •First chemotherapy cure (C1D1) not initiated yet
- •Patients with a complete healing after resection (for adjuvant chemotherapy)
- •Patients that do not report residual pain with an intensity >
- •For head, neck and bladder cancer cohort :
- •Adult patient (>18 years)
- •Histological or cytological proven head, neck or bladder cancer
- •Patient eligible for an adjuvant or neoadjuvant based on cisplatin.
- •Therapeutic strategy validated in multidisciplinary meeting
- •First chemotherapy cure (C1D1) not initiated yet
- •Patients with a complete healing after resection.
- •Patients that do not report residual pain with an intensity >
- •For invasive act leading to potential anxiety cohort :
- •Adult patient (>18 years)
- •Histological or cytological proven cancer
- •Patient with a planned hospitalization at oncological unit
- •Eupneic patient
- •Afebrile patient
- •Patient for whom an invasive act leading to potential anxiety is planned (excluding percutaneous implantable chamber) :
- •Deep biopsy
- •Endoscopy without general anesthesia
- •myelogram
排除标准
- •Patient with a consciousness disturbance or a spatio-temporal disturbance
- •Claustrophobic patient
- •Patient with a non-stabilized psychiatric pathology
- •Patient with seizure crisis background
- •Patient with a visual or hearing disturbance that is not compatible with video watching and sound listening
- •Patients with out-of range clinical parameters (arterial pressure, cardiac frequency,..)
- •Patients with out-of range blood parameters that are not compatible with chemotherapy or an invasive act.
- •Patient with a life expectancy below 3 months.
- •Impossibility to track and follow patient (any reason)
- •Patient deprived of liberty or subjected to guardianship
结局指标
主要结局
Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure
时间窗: Before an invasive act or a chemotherapy
Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) before patients undergo an oncologic procedure (invasive act or chemotherapy (C1D1).
次要结局
- Determination of patient anxiety level evolution through 3 cycles of chemotherapy(just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy)
- Difference of anxiety using the State-Trait Anxiety Inventory before chemotherapy(Just before chemotherapy)
- Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure(Before an invasive act or a chemotherapy)
- Difference of anxiety using the State-Trait Anxiety Inventory before invasive act(Just before an invasive act)
- Patient basal anxiety level just before an oncologic procedure(Just before an oncologic procedure)