NCT06552091

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Institut de Cancérologie de Lorraine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
OTHER	self-hypnosis sessions	3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily

Timeline

• Start date: 2024-10-17
• Primary completion: 2026-04-30
• Completion: 2027-02-17
• First posted: 2024-08-13
• Last updated: 2026-02-17

Locations

1 site across 1 country: France