Digital self-hypnosis for managing hot flashes in breast cancer patients on hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a guided digital self-hypnosis solution aimed at reducing hot flashes in women undergoing hormone therapy for non-metastatic breast cancer. The study targets patients who experience significant hot flashes, which can adversely affect their treatment adherence and overall quality of life. By employing a non-pharmacological approach, the trial seeks to alleviate the side effects associated with hormone therapy, potentially improving treatment outcomes and patient well-being. Participants will engage in self-hypnosis sessions accessed through a computer device.

Why it matters

Who can join: the full rules

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).

Where it's running

• Institut de Cancerologie de Lorraine
  Vandœuvre-lès-Nancy, France Recruiting

Study contacts

• Principal investigator: Aurelien Lambert, Md — Institut de Cancérologie de Lorraine
• Study coordinator: Jean Louis Merlin, Puph
• Email: jl.merlin@nancy.unicancer.fr
• Phone: +33 3 83 65 60 62

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.