Using sophrology to reduce anxiety in breast cancer patients undergoing chemotherapy
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.
NA · Institut Cancerologie de l'Ouest · NCT06800989
This study is testing if a relaxation technique called sophrology can help reduce anxiety in breast cancer patients who are receiving chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Cancerologie de l'Ouest (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Angers and 2 other locations) |
| Trial ID | NCT06800989 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of sophrology, a relaxation technique, assisted by an ambulatory device in alleviating anxiety among patients with localized breast cancer undergoing chemotherapy. The intervention aims to address the high levels of anxiety reported by patients at the time of diagnosis and during treatment. Participants will engage in sophrology sessions to help manage their emotional well-being throughout their cancer treatment journey. The study will include patients who are 18 years or older and require chemotherapy, with careful selection based on specific inclusion and exclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with localized breast cancer who are about to undergo chemotherapy.
Not a fit: Patients with metastatic breast cancer or those with a history of severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety levels in breast cancer patients, improving their overall treatment experience and mental health.
How similar studies have performed: Previous studies have shown promising results in using relaxation techniques like sophrology for anxiety management in cancer patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 2 other locations
- Institut de Cancérologie de l'Ouest - site Angers — Angers, France (RECRUITING)
- CH Cholet — Cholet, France (ACTIVE_NOT_RECRUITING)
- Institut de Cancérologie de l'Ouest - site Saint Herblain — Saint-Herblain, France (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Simmet — Institut de Cancérologie de l'Ouest
- Study coordinator: Victor Simmet, MD
- Email: victor.simmet@ico.unicancer.fr
- Phone: +33 2 41 35 27 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Female, anxiety, sophrology, breast cancer