RecruitingNot ApplicableNCT06552091

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


Sponsor

Institut de Cancérologie de Lorraine

Enrollment

76 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a digital self-hypnosis program to help reduce hot flashes in women with non-metastatic (non-spread) breast cancer who are taking hormone-blocking medications (anti-aromatase therapy). Hot flashes are a common and disruptive side effect of these treatments. **You may be eligible if...** - You are an adult woman being treated for non-metastatic breast cancer - You are currently on adjuvant (post-treatment) hormone-blocking therapy - You are experiencing at least 50 hot flashes per week (or 7 per day) - You have a computer or device that can access the self-hypnosis program - You read and understand French **You may NOT be eligible if...** - You are male - You have hearing problems, cognitive disorders, or psychotic illness - You have fewer than 50 hot flashes per week - You have previously done hypnosis or self-hypnosis - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERself-hypnosis sessions

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


Locations(1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

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NCT06552091


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