Breast Cancer Clinical Trial
— HYGEEOfficial 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.
Verified date | December 2023 |
Source | Fondation Hôpital Saint-Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 27 |
Est. completion date | January 30, 2024 |
Est. primary completion date | March 23, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Fondation Hôpital Saint-Joseph |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | Difference between the 2 groups of patients in terms of IgA level evolution | Day 7 and 1 year |
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