AnxietyREVNCT04419077
Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
A study testing Virtual reality exposure in people with Anxiety and Chemotherapy Effect, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Chemotherapy Effect, Breast Cancer
- What is being tested?
- Virtual reality exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2020to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 31Show fewer
- 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
Who cannot join
- 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,..)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud
Pierre-Bénite, 69495
About this study
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.
Read more
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.
Read the 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
- Being tested
- Virtual reality exposure
- Keywords
- Hypnosis
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality exposure | Other | Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy) Receives: Behavioral: Virtual reality exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before an invasive act or a chemotherapy
Secondary outcomes (5)
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)
Measured: Before an 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
Measured: 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
Measured: 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)
Measured: Just before an oncologic procedure
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
Measured: just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start7 Jun 2020
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419077
- Sponsor's protocol ID
- 69HCL19_0992
- Acronym
- REV
- Status last verified
- Sep 2023
- First submitted
- 2 Mar 2020
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act
- ClinicalTrials.gov ID
- NCT04419077
- Acronym / sponsor ID
- REV / 69HCL19_0992
- Conditions
- Anxiety, Chemotherapy Effect, Breast Cancer, Head Cancer Neck
- Keywords
- Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality exposure | Other | Behavioral: Virtual reality exposureVirtual reality exposure just before an oncological procedure (invasive act or a chemotherapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Patient Study Information and written informed consent
- Social Security Affiliation
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exposurePatients 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. | Behavioural | Virtual reality exposure |
Primary outcome
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).
5 secondary outcomes
Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure
Time frame: 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 using the State-Trait Anxiety Inventory before invasive act
Time frame: Just before an invasive act
Patient basal anxiety level just before an oncologic procedure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exposure in people with Anxiety and Chemotherapy Effect, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure (time frame: Before an invasive act or a chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.