Using sophrology to reduce anxiety in breast cancer patients undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.