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

  • STATUS
    Recruiting
  • End date
    Dec 7, 2022
  • participants needed
    66
  • sponsor
    Hospices Civils de Lyon
Updated on 21 July 2021
cyclophosphamide
doxorubicin
docetaxel
trastuzumab
epirubicin
adjuvant chemotherapy
immunomodulator

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.

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.

Details
Condition cancer of the head and neck, breast carcinoma, Anxiety Disorders, head and neck cancer, Breast Cancer Diagnosis, anxious, Generalized Anxiety Disorder (GAD), ANXIETY NEUROSIS, Breast Cancer, Anxiety Disorders (Pediatric), Anxiety, Chemotherapy Effect, anxiety disorder, Head and Neck Cancer, cancer, breast, Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Symptoms
Treatment Virtual Reality Exposure
Clinical Study IdentifierNCT04419077
SponsorHospices Civils de Lyon
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note