RecruitingNot Applicable

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

France76 participantsStarted 2024-10-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hot Flash Score (HFS)

Timeframe: 28 days

Trial details

NCT IDNCT06552091

SponsorInstitut de Cancérologie de Lorraine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

JEAN LOUIS MERLIN, PUPH

+33 3 83 65 60 62 jl.merlin@nancy.unicancer.fr

View on ClinicalTrials.gov More Breast Cancer Female trials