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

Primary Purpose

Anxiety, Chemotherapy Effect, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality exposure
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Hypnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Virtual reality exposure

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure
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)
Difference of anxiety using the State-Trait Anxiety Inventory 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
Difference of anxiety using the State-Trait Anxiety Inventory before 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
Patient basal anxiety level 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)
Determination of patient anxiety level evolution through 3 cycles 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

Full Information

First Posted
March 2, 2020
Last Updated
September 1, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04419077
Brief Title
Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
Acronym
REV
Official Title
Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2020 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Chemotherapy Effect, Breast Cancer, Head Cancer Neck
Keywords
Hypnosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
44 patients for the cohort " chemotherapy " and 22 patients for the cohort " invasive act ".
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality exposure
Arm Type
Other
Arm Description
Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy)
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality exposure
Intervention 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.
Primary Outcome Measure Information:
Title
Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure
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).
Time Frame
Before an invasive act or a chemotherapy
Secondary Outcome Measure Information:
Title
Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure
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)
Time Frame
Before an invasive act or a chemotherapy
Title
Difference of anxiety using the State-Trait Anxiety Inventory 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
Time Frame
Just before chemotherapy
Title
Difference of anxiety using the State-Trait Anxiety Inventory before 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
Time Frame
Just before an invasive act
Title
Patient basal anxiety level 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)
Time Frame
Just before an oncologic procedure
Title
Determination of patient anxiety level evolution through 3 cycles 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
Time Frame
just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

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

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