Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adju
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
| Condition(s) | Breast Cancer Female |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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-metas |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Institut de Cancérologie de Lorraine |
| Locations | Vandœuvre-lès-Nancy, France |
| Start date | 2024-10-17 |
| NCT ID | NCT06552091 |
| Official listing | https://clinicaltrials.gov/study/NCT06552091 |