<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04419077</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL19_0992</org_study_id>
    <nct_id>NCT04419077</nct_id>
  </id_info>
  <brief_title>Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act</brief_title>
  <acronym>REV</acronym>
  <official_title>Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the REV clinical trial is to evaluate the impact of a virtual reality exposure to&#xD;
      decrease patient anxiety before chemotherapy or an invasive act. If positive, the access to&#xD;
      virtual reality exposure is aimed to be used as standard of care at Lyon's hospital to&#xD;
      improve cancer patient well-being in a drug-free manner.&#xD;
&#xD;
      The majority of cancer patients lives with high level of anxiety as soon as diagnosed. This&#xD;
      level anxiety is particularly high before invasive acts but also before chemotherapy by side&#xD;
      effects anticipation.&#xD;
&#xD;
      Hypnosis is a highly interesting drug-free approach to decrease patient's anxiety. It however&#xD;
      requires on site specialists to be available whenever needed.&#xD;
&#xD;
      Virtual reality provides a distractive environment enabled to shift patient focus. It can&#xD;
      support a switch of patient mindset by providing positive emotions.&#xD;
&#xD;
      Since 5 years, this disruptive technology is being more and more used as medical support&#xD;
      thanks to a new generation of headsets enabling improved performance at cheaper prices.&#xD;
&#xD;
      Many publications have now demonstrated the positive impact of virtual reality to take in&#xD;
      charge patients' pain or pre-operational anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the REV study is to demonstrate the difference of anxiety before and&#xD;
      after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y) before&#xD;
      patients undergo an oncological procedure (invasive act or chemotherapy (C1D1).&#xD;
&#xD;
      The investigator's REV study aims to recruit 66 patients among three cohorts (22 patients per&#xD;
      cohort) in 12 months.&#xD;
&#xD;
        -  Breast cancer cohort (patient receiving an adjuvant or neoadjuvant chemotherapy with&#xD;
           doxorubicin and cyclophosphamide)&#xD;
&#xD;
        -  Head or neck cancer cohort (patient treated by concomitant radiochemotherapy)&#xD;
&#xD;
        -  Cancer patient for which an invasive act inducing anxiety is planned (lumbar puncture,&#xD;
           ascites puncture, thoracocentesis, myelogram, bone marrow biopsy, urinary&#xD;
           catheterization, ..)&#xD;
&#xD;
      The REV study aims to impact Lyon's hospital patients' quality of life and well-being by&#xD;
      decreasing their anxiety level during oncological treatments thanks to innovative supportive&#xD;
      cares.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2020</start_date>
  <completion_date type="Actual">June 16, 2022</completion_date>
  <primary_completion_date type="Actual">June 16, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>44 patients for the cohort &quot; chemotherapy &quot; and 22 patients for the cohort &quot; invasive act &quot;.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure</measure>
    <time_frame>Before an invasive act or a chemotherapy</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure</measure>
    <time_frame>Before an invasive act or a chemotherapy</time_frame>
    <description>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).&#xD;
Comparison of responses between self-evaluation anxiety inventory before and after virtual reality exposure just before an oncologic procedure (invasive act or a chemotherapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of anxiety using the State-Trait Anxiety Inventory before chemotherapy</measure>
    <time_frame>Just before chemotherapy</time_frame>
    <description>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).&#xD;
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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference of anxiety using the State-Trait Anxiety Inventory before invasive act</measure>
    <time_frame>Just before an invasive act</time_frame>
    <description>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.&#xD;
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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient basal anxiety level just before an oncologic procedure</measure>
    <time_frame>Just before an oncologic procedure</time_frame>
    <description>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).&#xD;
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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of patient anxiety level evolution through 3 cycles of chemotherapy</measure>
    <time_frame>just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy</time_frame>
    <description>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).&#xD;
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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Anxiety</condition>
  <condition>Chemotherapy Effect</condition>
  <condition>Breast Cancer</condition>
  <condition>Head Cancer Neck</condition>
  <arm_group>
    <arm_group_label>Virtual reality exposure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual reality exposure</intervention_name>
    <description>Patients will be exposed to a 10-20 min virtual reality session just before an oncological procedure (invasive act or chemotherapy).&#xD;
Patients will be able to choose between 4 virtual universes (beach, underwater, forest, space) and seven musical content.</description>
    <arm_group_label>Virtual reality exposure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For all patients:&#xD;
&#xD;
          -  Patient Study Information and written informed consent&#xD;
&#xD;
          -  Social Security Affiliation&#xD;
&#xD;
        For breast cancer cohort :&#xD;
&#xD;
          -  Adult patient (&gt;18 years)&#xD;
&#xD;
          -  Histological or cytological proven breast cancer&#xD;
&#xD;
          -  Eligible to an adjuvant or neo-adjuvant IV chemotherapy given every 2 to 3 weeks (with&#xD;
             protocol doxorubicin- cyclophosphamide, docetaxel-cyclophosmadide,&#xD;
             docetaxel-cyclophosphamide-trastuzumab, docetaxel, carboplatine, trastuzumab,&#xD;
             epirubicin-cyclophosphamide, etc)&#xD;
&#xD;
          -  Therapeutic strategy validated in multidisciplinary meeting&#xD;
&#xD;
          -  First chemotherapy cure (C1D1) not initiated yet&#xD;
&#xD;
          -  Patients with a complete healing after resection (for adjuvant chemotherapy)&#xD;
&#xD;
          -  Patients that do not report residual pain with an intensity &gt; 4.&#xD;
&#xD;
        For head, neck and bladder cancer cohort :&#xD;
&#xD;
          -  Adult patient (&gt;18 years)&#xD;
&#xD;
          -  Histological or cytological proven head, neck or bladder cancer&#xD;
&#xD;
          -  Patient eligible for an adjuvant or neoadjuvant based on cisplatin.&#xD;
&#xD;
          -  Therapeutic strategy validated in multidisciplinary meeting&#xD;
&#xD;
          -  First chemotherapy cure (C1D1) not initiated yet&#xD;
&#xD;
          -  Patients with a complete healing after resection.&#xD;
&#xD;
          -  Patients that do not report residual pain with an intensity &gt; 4.&#xD;
&#xD;
        For invasive act leading to potential anxiety cohort :&#xD;
&#xD;
          -  Adult patient (&gt;18 years)&#xD;
&#xD;
          -  Histological or cytological proven cancer&#xD;
&#xD;
          -  Patient with a planned hospitalization at oncological unit&#xD;
&#xD;
          -  Eupneic patient&#xD;
&#xD;
          -  Afebrile patient&#xD;
&#xD;
        Patient for whom an invasive act leading to potential anxiety is planned (excluding&#xD;
        percutaneous implantable chamber) :&#xD;
&#xD;
          -  Puncture&#xD;
&#xD;
          -  Deep biopsy&#xD;
&#xD;
          -  Sounding&#xD;
&#xD;
          -  Endoscopy without general anesthesia&#xD;
&#xD;
          -  myelogram&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a consciousness disturbance or a spatio-temporal disturbance&#xD;
&#xD;
          -  Claustrophobic patient&#xD;
&#xD;
          -  Patient with a non-stabilized psychiatric pathology&#xD;
&#xD;
          -  Patient with seizure crisis background&#xD;
&#xD;
          -  Patient with a visual or hearing disturbance that is not compatible with video&#xD;
             watching and sound listening&#xD;
&#xD;
          -  Patients with out-of range clinical parameters (arterial pressure, cardiac&#xD;
             frequency,..)&#xD;
&#xD;
          -  Patients with out-of range blood parameters that are not compatible with chemotherapy&#xD;
             or an invasive act.&#xD;
&#xD;
          -  Patient with a life expectancy below 3 months.&#xD;
&#xD;
          -  Impossibility to track and follow patient (any reason)&#xD;
&#xD;
          -  Patient deprived of liberty or subjected to guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>March 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04419077
org study id: 69HCL19_0992
nct id: NCT04419077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: 44 patients for the cohort " chemotherapy " and 22 patients for the cohort " invasive act ".
measure: Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure
time frame: Before an invasive act or a chemotherapy
description: 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).
measure: Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure
time frame: Before an invasive act or a chemotherapy
description: 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)
measure: Difference of anxiety using the State-Trait Anxiety Inventory before chemotherapy
time frame: Just before chemotherapy
description: 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
measure: Difference of anxiety using the State-Trait Anxiety Inventory before invasive act
time frame: Just before an invasive act
description: 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
measure: Patient basal anxiety level just before an oncologic procedure
time frame: Just before an oncologic procedure
description: 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)
measure: 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
description: 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
arm group label: Virtual reality exposure
arm group type: Other
description: Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy)
intervention type: Behavioral
intervention name: Virtual reality exposure
description: 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.
arm group label: Virtual reality exposure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Anxiety Disorders