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

NCT ID: NCT04419077

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-07
• Study Completion Date: 2022-06-16

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.

Conditions

Anxiety; Chemotherapy Effect; Breast Cancer; Head Cancer Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual reality exposure

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

Group Type: OTHER

Virtual reality exposure

Intervention Type: 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.

Interventions

Virtual reality exposure

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Pierre-Bénite, , France

Countries

France

Other Identifiers

69HCL19_0992

Identifier Type: -

Identifier Source: org_study_id