Status:
RECRUITING
Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Hormone Therapy
Lead Sponsor:
Institut de Cancérologie de Lorraine
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 prescri...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 17 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06552091
Start Date
October 17 2024
End Date
February 17 2027
Last Update
November 24 2025
Active Locations (1)
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1
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France, 54500