To Assess the Contribution of Sophrology Assisted by an Ambulatory Device on the Anxiety of Patients Undergoing Chemotherapy for the Treatment of Localized Breast Cancer

Launched by INSTITUT CANCEROLOGIE DE L'OUEST · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how a device called Morphée® can help reduce anxiety in women receiving chemotherapy for localized breast cancer. Many women experience high levels of anxiety when diagnosed with cancer and during treatment, which can affect their overall well-being. The trial aims to see if using this device for sophrology, a relaxation technique that promotes mindfulness and positive thinking, can support these patients in managing their anxiety better.

To participate in the trial, women must be over 18 years old, diagnosed with localized breast cancer, and require chemotherapy. They also need to understand French and have national health insurance. Participants will have the opportunity to use the Morphée® device to practice sophrology, which can be done anytime and anywhere, making it easier for them to access this supportive care. The trial will help determine if this approach can improve the quality of life for women undergoing chemotherapy for breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient with localized breast cancer
• • 2. Patient \> 18 years old
• • 3. Patient requiring chemotherapy +/- combined with immunotherapy or targeted therapy, in neoadjuvant or adjuvant seeting defined by the multidisciplinary consultation meeting.
• • 4. Patient with signed consent
• • 5. Patient has national health insurance coverage
• Exclusion Criteria:
• • 1. Patient previously treated with chemotherapy for breast cancer
• • 2. Patient with metastatic breast cancer
• • 3. History of psychiatric illness or treatment with neuroleptics, antidepressants or thymoregulators thymoregulator, prior to discovery of cancer (except resolved depressive episode, without psychiatric treatment for at least 2 years). An anxiolytic or hypnotic treatment prescribed after diagnosis is authorized
• • 4. Patient suffering from psychiatric disorders, delusional phases, schizophrenia contraindicating practice of sophrology
• • 5. Patient who has already had an introduction to sophrology in the context of her pathology, or who plans to start sophrology within within 3 months of the start of treatment outside the hospital structure and by her own means
• • 6. Patient does not understand or speak French
• • 7. Cognitive impairment or inability to understand, compromising participation in the study and use and understanding of the device
• • 8. Patient under legal protection, guardianship or trusteeship
• • 9. Inability to undergo protocol monitoring for geographical or social reasons.
• • 10. Patient participating in another interventional study evaluating supportive care