Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Hormone Therapy
Launched by INSTITUT DE CANCÉROLOGIE DE LORRAINE · Aug 12, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a daily guided self-hypnosis program can help reduce hot flashes in women undergoing hormone therapy for non-metastatic breast cancer. Hot flashes are a common side effect of the treatment and can significantly affect a patient's quality of life and ability to stick to their prescribed medication. By using a digital self-hypnosis solution, the trial aims to see if it can help women feel better and improve their overall treatment experience.
To participate in this study, women aged 65 to 74 who are currently being treated for non-metastatic breast cancer and experience at least 50 hot flashes a week may be eligible. Participants will take part in guided self-hypnosis sessions over three weeks, focusing on different themes. They will also provide feedback on their quality of life, sleep quality, and satisfaction with care. This trial not only hopes to help manage hot flashes but also to enhance the participants' overall well-being during their treatment journey.
Gender
FEMALE
Eligibility 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).
About Institut De Cancérologie De Lorraine
The Institut de Cancérologie de Lorraine (ICL) is a leading cancer research and treatment center in France, dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. With a focus on multidisciplinary collaboration, ICL integrates cutting-edge research with clinical practice to enhance therapeutic outcomes and improve the quality of life for cancer patients. The institute is committed to fostering scientific discovery and translating findings into effective treatments, while adhering to the highest ethical standards in clinical research. Through its robust portfolio of clinical trials, ICL aims to contribute significantly to the understanding and management of various cancer types.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vandœuvre Lès Nancy, , France
Patients applied
Trial Officials
AURELIEN AL LAMBERT, MD
Principal Investigator
Institut de Cancérologie de Lorraine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported