Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Toolalong the Care Pathway of Patients Undergoing Breast Cancer Treatment. (HYGEE)

December 14, 2023 updated by: Fondation Hôpital Saint-Joseph

Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Tool Along the Care Pathway of Patients Undergoing Breast Cancer Treatment: Randomized Controlled Trial.

In 2017, it is estimated that nearly 60,000 new cases of breast cancer will be diagnosed in France. Although several treatments are indicated in this context, chemotherapy remains a curability option whose place today extends to small tumors to support its increasingly approved administration contributing to a continuous increase in survival rates.

However, diagnostic procedures and anti-cancer treatments are frequently responsible for toxicity that can reach high levels of severity and even generate sequelae.

These physical and psychological after-effects of breast cancer treatment have a short and medium-term impact on the quality of life of the patients treated: anxiety, fear, pain, job loss, and the onset of precariousness.

In addition, surgical procedures such as PAC and pic-line surgery are often associated with anxiety and pain. Chemotherapy is particularly associated with anxiety, stress, fatigue, nausea and vomiting.

Some immediate, delayed or even anticipated side effects are not always effectively controlled by the medication available to us. Anti-nausea medications can lead to drug interactions and/or other adverse effects. The interest of a non-drug approach is to get rid of these adverse effects. However, it is underestimated and therefore currently not integrated into current practice.

Its benefits must therefore be explored within the framework of in-depth research protocols that justify our study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 use of virtual reality (VR) technology as a non-pharmacological tool has developed public interest in improving the control of certain adverse effects induced by chemotherapy. A few small studies suggest that the use of VR during chemotherapy helps reduce anxiety, fatigue and nausea and vomiting. Schneider showed improvement in stress-related symptoms such as anxiety in children aged 10 years and older receiving chemotherapy treatment during a VR session.

A similar study showed a reduction in anxiety in patients receiving chemotherapy for breast cancer treatment coupled with VR. Dr. Hoffman is recognized as a pioneer in the use of VR, which he has proven to be effective in the care of burn patients, coupled with a technique that some have called VR analgesia. He has demonstrated that this technology used in this setting is a novel non-pharmacological approach to improving pain control.

Our project involves the use of a VR module associated with an application delivering hypnotherapy combined with cognitive behavioral therapy that could help improve the adverse effects attributable to chemotherapy. The hypnotherapy that has been shown to be medically effective since its discovery by Mesmer is Ericksonian hypnosis. It usually involves an exchange between the therapist and the patient over a period of time.

marked (suggestion, induction, fascination, dissociation, amplification) which has evolved in our institution in a less elaborate form called "conversational hypnosis".

In this context, VR hypnotherapy appears to be a promising alternative. To date, there are a few studies that demonstrate the reduction of anxiety through the use of this tool during the application of PACs and pick-lines.

The innovation of this study is to report the effects of a combination of hypnotherapy using VR through a program aimed at modifying the experience of adverse effects due to PAC and chemotherapy in the care pathway of breast cancer patients.

It will also be compared to what is called in our institution and practiced routinely: conversational hypnosis which is not Ericksonian hypnosis strictly speaking but because of the parameters mentioned above: time, human resources load has become a simple benevolent conversation that welcomes the patient in every step of his care.

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.
27

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 Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

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:

  • Woman whose age ≥ 18 years old
  • Negative pregnancy test for women of childbearing age
  • Francophone patient
  • Patient newly diagnosed with localized or metastatic breast cancer at the Paris Saint-Joseph Hospital Group (GhPSJ).
  • Patients in whom adjuvant or neoadjuvant chemotherapy treatment is planned
  • Patient affiliated to the social security system or, failing that, to another health insurance system
  • Patient who has given written consent.

Exclusion Criteria:

  • Psychotic patients (paranoia, schizophrenia and manic-depressive psychosis)
  • Patient suffering from pathological dissociations
  • Deaf and hard of hearing
  • Blind and severely visually impaired
  • Patient suffering from wounds or infections in the head area
  • Patient suffering from respiratory disorders
  • Patient with a high level of claustrophobia
  • Patient whose investigator determines that he or she cannot wear a virtual reality helmet
  • Patient under guardianship or curatorship
  • Patient deprived of liberty.
  • Pregnant or breastfeeding patient.

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: Randomized
  • Interventional Model: Parallel 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.
No Intervention: no hypnotherapy
A "control" group of patients receiving the usual management for PAC and chemotherapy sessions.
Experimental: hypnotherapy
A "hypnotherapy" group of patients benefiting from hypnotherapy sessions prior to PAC and chemotherapy cures in addition to the usual management.
Device: Oncomfort® clinical virtual reality

hypnotherapy" arm, patients will receive in addition to the care provided by the usual :

  • for PAC insertion: a 45-minute hypnotherapy session 2 hours before the procedure in a room of the outpatient surgery unit (UCA).
  • during the entire duration of chemotherapy (and/or immunotherapy for HER2+ patients) : one hypnotherapy session before the first treatment and then every 3 weeks. One hypnotherapy session before the first treatment and then every 3 weeks. Thus, sessions will take place before each treatment for 3-week inter-course regimens and every 3 treatments for chemotherapy administered on a weekly. Each session will last 20 minutes.

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
Evaluate, in patients undergoing chemotherapy for the treatment of breast cancer, the impact of the use of hypnotherapy performed by a virtual reality tool on the anxiety felt just before the PAC procedure.
Time Frame: Day 7

Difference between the 2 groups of patients in terms of the anxiety felt just before the PAC procedure, evaluated by the Spielberger's State Anxiety Scale (STAI form Y-A).

This scale evaluates the feelings of apprehension, tension, nervousness and anxiety that the subject feels at the time of the anxiety-provoking or competitive situation.
Day 7

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
Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy performed by a virtual reality tool on the maximum pain and its duration felt by patients since the insertion of PAC.
Time Frame: Day 7
Difference between the 2 groups of patients in terms of maximum pain and its duration felt by the patients since PAC insertion evaluated on an numerical scale 30 minutes after PAC insertion
Day 7
Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on the incidence of chemotherapy associated adverse events.
Time Frame: Day 7
Difference between the 2 groups of patients in terms of frequency of nausea, vomiting, fatigue and peripheral neuropathies after chemotherapy cures, reported on questionnaire QLQ-C30
Day 7
Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on quality of life as measured by the QLC30 scale at the end of chemotherapy.
Time Frame: 1 year
Difference between the 2 groups of patients in terms of the score of the "globalhealth" section of the QLQ-C30 questionnaire at the end of chemotherapy
1 year
Evaluate in patients undergoing chemotherapy for the treatment of breast cancer the impact of the use of hypnotherapy using a virtual reality tool on the quality of life measured on the QBR23 scale at the end of chemotherapy.
Time Frame: 1 year
Difference between the 2 groups of patients in terms of the quality of life score from the QLQ-QBR23 questionnaire at the end of the chemotherapy
1 year
Evaluate the impact of the use of hypnotherapy on the immune system in patients undergoing chemotherapy for the treatment of breast cancer using a virtual reality tool.
Time Frame: Day 7 and 1 year
Difference between the 2 groups of patients in terms of IgA level evolution
Day 7 and 1 year

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.
Fondation Hôpital Saint-Joseph

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathalie GARNIER-VIOUGEAT, MD, Fondation Hôpital Saint-Joseph

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.
September 24, 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.
March 23, 2022

Study Completion (Estimated)

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.
January 30, 2024

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).
September 10, 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.
September 28, 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.
October 5, 2020

Study Record Updates

Last Update Posted (Estimated)

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.
December 15, 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.
December 14, 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.
December 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.
  • HYGEE

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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