Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act (REV)

Civil Hospices of Lyon

Status

Completed

Conditions

Breast Cancer

Chemotherapy Effect

Head Cancer Neck

Anxiety

Treatments

Behavioral: Virtual reality exposure

Study type

Interventional

Funder types

Other

Identifiers

NCT04419077

69HCL19_0992

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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