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

Official title

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.

Overview

Patients with localized breast cancer undergo treatment that includes breast surgery, which always alters their body image, complemented by optional additional treatments depending on the specifics and severity of their disease. These treatments are multimodal and may include chemotherapy, radiotherapy, targeted anticancer treatments, and hormone therapy, followed by prolonged monitoring for at least 5 years. A recent study showed that the announcement of cancer and its treatments is a source of reactive anxiety for 47% of patients at the time of diagnosis, which can be associated with depression in 59% of cases before chemotherapy. Anxiety increases with the intensity of treatments and is higher when chemotherapy is administered, especially in younger patients (under 50 years old). The integrative multidisciplinary care available in treatment centers (psychologist, adapted physical activity, socio-aesthetician), combined with external support through associative networks (art therapy, music therapy, etc.), is crucial for improving quality of life and treatment side effects. Sophrology is one of these complementary therapies recommended by Association Francophone Des Soins Oncologiques De Support (French Association for Supportive Care in Oncology) within or outside the healthcare structure and is validated as supportive care. Its principle is to positively enhance patients' qualities and resources by altering states of consciousness, allowing individuals to find a balance between their thoughts, emotions, and behaviors. The three fundamental principles are to bring the body schema to a more lived reality, reinforce positive action, and develop objective reality. The "mindfulness" techniques used in sophrology include dynamic relaxation and sophronizations. Sophrology is based on the scientific principles of mindfulness meditation (developing attentional resources and body awareness by modulating brain waves). Studies have shown the benefits of mindfulness in managing stress, certain psychosomatic conditions, and chronic pain. Improvements in overall quality of life, stress symptoms, and sleep quality have been reported in the evaluation of a mindfulness meditation program for cancer patients. A trial demonstrated the beneficial effect of group mindfulness meditation on the anxiety of women who had undergone chemotherapy for breast cancer. Today, although sophrology is regularly used in medical care, no robust scientific study has evaluated its benefit in oncology. Institut National de la Santé et de la Recherche Médicale, together with Haute Autorité de la Santé, highlighted in its 2020 report on sophrology the significant need to scientifically assess the interest of sophrology in medical care. However, the use and accessibility of complementary therapies, including sophrology, are very unequal across France and depend on hospitals, geography, patient mobility, and sometimes the financial ability of patients to access paid complementary therapies. As a result, many anxious patients cannot access sophrology sessions at the desired time due to geographical, accessibility, human resource, and sometimes financial reasons (outside the hospital). The Morphée® device could help reduce these disparities and accessibility issues by allowing patients to perform a sophrology session at any time and place after receiving explanations from a healthcare professional.

Interventions

• Behavioral sophrology sessions
  Two sophrology sessions will be conducted in the experimental group. The first session (S1) should take place on Cycle 1 Day 1 or within a maximum of 3 weeks following Cycle 1 Day 1. The second session (S2) should be conducted within 3 to 4 weeks after the first session.
• Device Morphee Device
  Patients will be encouraged to perform at least one daily ambulatory sophrology session with the Morphée® device, according to a support plan defined with the sophrologist.

Primary outcome measures

• To measure the evolution of anxiety in patients undergoing adjuvant or neoadjuvant chemotherapy treatment, depending on whether they benefit from a sophrology program through an ambulatory sophrology device (Morphée®) [Time frame: Inclusion and 3 months after start of treatment]

Eligibility criteria

Inclusion criteria

• Patient with localized breast cancer
• Patient > 18 years old
• Patient requiring chemotherapy +/- combined with immunotherapy or targeted therapy, in neoadjuvant or adjuvant seeting defined by the multidisciplinary consultation meeting.
• Patient with signed consent
• Patient has national health insurance coverage

Exclusion criteria

• Patient previously treated with chemotherapy for breast cancer
• Patient with metastatic breast cancer
• 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
• Patient suffering from psychiatric disorders, delusional phases, schizophrenia contraindicating practice of sophrology
• 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
• Patient does not understand or speak French
• Cognitive impairment or inability to understand, compromising participation in the study and use and understanding of the device
• Patient under legal protection, guardianship or trusteeship
• Inability to undergo protocol monitoring for geographical or social reasons.
• Patient participating in another interventional study evaluating supportive care

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 3 centers

• Institut de Cancérologie de l'Ouest - site Angers — Angers
• CH Cholet — Cholet
• Institut de Cancérologie de l'Ouest - site Saint Herblain — Saint-Herblain

Identifiers

NCT: NCT06800989 · ICO-2024-11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗