Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy

Обзор

Patients treated for breast cancer with hormone therapy (HT) suffer from hot flashes. This side effect impacts treatment adherence. Indeed, approximately 50% of women take less than 80% of the prescribed dose, and up to 50% abandon their treatment before the fifth year of prescription, significantly increasing the risk of recurrence. Moreover, these hot flashes strongly impact the quality of life. According to the CANTO study, these hot flashes can persist up to two years after diagnosis, affecting social relationships, return to work, and physical and mental health. Some side effects resulting from HT (sleep disturbances, fatigue, hot flashes) could be alleviated by a non-pharmacological approach involving the patient. Our hypothesis is that a non-pharmacological solution, such as the use of self-hypnosis, could reduce hot flashes and the side effects related to HT or the perception thereof in patients treated for breast cancer. Consequently, this could improve the quality of life and lead to better treatment adherence. The principal objective is to evaluate the effect of daily guided self-hypnosis sessions in reducing hot flashes in patients with non-metastatic breast cancer receiving anti-aromatase hormone therapy. The secondary objectives are to evaluate : * Patient adherence to guided self-hypnosis via a digital solution * Quality of life * Sleep quality * Satisfaction with care * Usability of the digital tool The originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.

Вмешательства

• Другое self-hypnosis sessions
  3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily

Первичные конечные точки

• Hot Flash Score (HFS) [Срок оценки: 28 days]

Вторичные конечные точки (5)

• Patient adherence [Срок оценки: 28 days]
• Score of quality of life [Срок оценки: 28 days]
• Sleep quality [Срок оценки: 28 days]
• Patient satisfaction [Срок оценки: 28 days]
• Usability of the digital tool [Срок оценки: 28 days]

Критерии участия

Критерии включения

• Adult patient,
• WHO ≤ 2,
• Patient who is premenopausal, perimenopausal, or postmenopausal at diagnosis,
• Patient being treated for non-metastatic breast cancer,
• Ongoing adjuvant endocrine therapy, with or without concomitant anti-CDK 4/6 targeted therapy,
• Patient reporting at least 50 hot flashes per week or at least 7 hot flashes per day
• Patient has a computer device capable of accessing the self-hypnosis program link,
• Information provided and informed consent signed,
• Patient affiliated with the social security system.

Критерии исключения

• Male,
• Patient with hearing impairments,
• Patient with psychotic and/or cognitive disorders As assessed by the clinician,
• Patient who does not understand the French language,
• Patient not diagnosed with non-metastatic breast cancer,
• Patient not undergoing anti-aromatase treatment,
• Patient reporting fewer than 50 hot flashes per week or fewer than 7 hot flashes per day,
• Prior participation in a hypnosis or self-hypnosis program before inclusion,
• Patient participating in a therapeutic program related to hot flashes,
• Patient already included in another therapeutic trial on the same topic,
• Patient already included in another therapeutic trial with an experimental drug,
• Pregnant or breastfeeding woman,
• Patient deprived of liberty (including guardianship and curatorship).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy

Идентификаторы

NCT: NCT06552091 · 2024-A01105-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗