Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Toolalong the Care Pathway of Patients Undergoing Breast Cancer Treatment.
NCT ID: NCT04574609
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
27 participants
INTERVENTIONAL
2020-09-24
2024-01-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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no hypnotherapy
A "control" group of patients receiving the usual management for PAC and chemotherapy sessions.
No interventions assigned to this group
hypnotherapy
A "hypnotherapy" group of patients benefiting from hypnotherapy sessions prior to PAC and chemotherapy cures in addition to the usual management.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Nathalie GARNIER-VIOUGEAT, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
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Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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HYGEE
Identifier Type: -
Identifier Source: org_study_id