Digital self-hypnosis for managing hot flashes in breast cancer patients on hormone therapy
Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy
This study tests if a guided digital self-hypnosis program can help women with breast cancer who are on hormone therapy reduce their hot flashes and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT06552091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult women diagnosed with non-metastatic breast cancer who are currently undergoing hormone therapy and report frequent hot flashes.
Not a fit: Patients who are male, have cognitive disorders, or do not meet the hot flash frequency criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for breast cancer patients experiencing hot flashes during hormone therapy.
How similar studies have performed: While the use of self-hypnosis for symptom management is a growing area of interest, this specific approach for hot flashes in breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vandœuvre-lès-Nancy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.