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

September 1, 2023 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Pierre-Bénite, France, 69495
        • Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Virtual reality exposure
Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy)
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure
Time Frame: Before an invasive act or a chemotherapy
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure
Time Frame: Before an invasive act or a chemotherapy

Difference of anxiety before and after a virtual reality exposure using a self-evaluation anxiety inventory before patients undergo an oncologic procedure (invasive act or chemotherapy (C1D1).

Comparison of responses between self-evaluation anxiety inventory before and after virtual reality exposure just before an oncologic procedure (invasive act or a chemotherapy)
Before an invasive act or a chemotherapy
Difference of anxiety using the State-Trait Anxiety Inventory before chemotherapy
Time Frame: Just before chemotherapy

Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) or the Self-evaluation anxiety inventory before patients undergo chemotherapy (C1D1, C2D1, C3D1).

Comparison of responses between the STAI-Y; A-State Scale or the Self-evaluation anxiety inventory before and after virtual reality exposure just before chemotherapy
Just before chemotherapy
Difference of anxiety using the State-Trait Anxiety Inventory before invasive act
Time Frame: Just before an invasive act

Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) or the Self-evaluation anxiety inventory before patients undergo an invasive act.

Comparison of responses between the STAI-Y; A-State Scale or the Self-evaluation anxiety inventory before and after virtual reality exposure just before an invasive act
Just before an invasive act
Patient basal anxiety level just before an oncologic procedure
Time Frame: Just before an oncologic procedure

Patient basal anxiety level using STAI-Y; A-State Scale, STAI-Y; Trait-State Scale or the Self-evaluation anxiety inventory just before an oncologic procedure (invasive act or a chemotherapy).

Quotation of patient basal anxiety level using STAI-Y; A-State Scale, STAI-Y; Trait-State Scale or the Self-evaluation anxiety inventory just before an oncological procedure (invasive act or a chemotherapy)
Just before an oncologic procedure
Determination of patient anxiety level evolution through 3 cycles of chemotherapy
Time Frame: just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy

Determination of patient anxiety level evolution through 3 cycles of chemotherapy using the STAI-Y; A-State Scale and the Self-evaluation anxiety inventory (just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy).

Comparison of responses between the STAI-Y; A-State Scale and the Self-evaluation anxiety inventory before virtual reality exposure, after virtual reality exposure and after 1 hour of chemotherapy
just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL19_0992

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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