Clinical trial NCT04419077: Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
Official title: Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Chemotherapy Effect
Breast Cancer
Head Cancer Neck
Keywords: Hypnosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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 \> 4.

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 \> 4.

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) :

* Puncture
* Deep biopsy
* Sounding
* Endoscopy without general anesthesia
* myelogram

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure
timeFrame: Before an invasive act or a chemotherapy
Secondary outcomes:
measure: Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure
timeFrame: Before an invasive act or a chemotherapy
measure: Difference of anxiety using the State-Trait Anxiety Inventory before chemotherapy
timeFrame: Just before chemotherapy
measure: Difference of anxiety using the State-Trait Anxiety Inventory before invasive act
timeFrame: Just before an invasive act
measure: Patient basal anxiety level just before an oncologic procedure
timeFrame: Just before an oncologic procedure
measure: Determination of patient anxiety level evolution through 3 cycles of chemotherapy
timeFrame: just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud
Study officials:
References: