Breast Cancer Clinical Trial
Official title:
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.
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.
;
NCT number | NCT04574609 |
Study type | Interventional |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | Nathalie GARNIER-VIOUGEAT, MD |
Phone | 01 44 12 77 72 |
[email protected] | |
Status | Recruiting |
Phase | N/A |
Start date | September 9, 2020 |
Completion date | September 9, 2023 |
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