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

NCT04419077 | Completed

• 1 other identifier: 69HCL19_0992
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Chemotherapy Effect; Breast Cancer; Head Cancer Neck

Keywords

Hypnosis

Outcome Measures

Primary Outcomes (1)

• Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure

  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).

  Before an invasive act or a chemotherapy

Secondary Outcomes (5)

• 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 chemotherapy

  Just before 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

• 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

Study Arms (1)

Virtual reality exposure

OTHER

Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy)

Behavioral: Virtual reality exposure

Interventions

Virtual reality exposure BEHAVIORAL

Patients will be exposed to a 10-20 min virtual reality session just before an oncological procedure (invasive act or chemotherapy). Patients will be able to choose between 4 virtual universes (beach, underwater, forest, space) and seven musical content.

Virtual reality exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Head and Neck Neoplasms

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 44 patients for the cohort " chemotherapy " and 22 patients for the cohort " invasive act ".
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: June 5, 2020
• Study Start: June 7, 2020
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

FR (1)