Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Hormone Therapy (HYBOU)

Institut de Cancérologie de Lorraine

Status

Enrolling

Conditions

Breast Cancer Female

Treatments

Other: self-hypnosis sessions

Study type

Interventional

Funder types

Other

Identifiers

NCT06552091

2024-A01105-42

Details and patient eligibility

About

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 of self-hypnosis, could reduce hot flashes and the side effects related to HT or the perception thereof in patients treated for breast cancer. Consequently, this could improve the quality of life and lead to better treatment adherence.

The principal objective is to evaluate the effect of daily guided self-hypnosis sessions in reducing hot flashes in patients with non-metastatic breast cancer receiving anti-aromatase hormone therapy.

The secondary objectives are to evaluate :

Patient adherence to guided self-hypnosis via a digital solution
Quality of life
Sleep quality
Satisfaction with care
Usability of the digital tool

The originality of this clinical trial is the proposal of self-hypnosis sessions over three weeks with three different themes using a digital solution.

Enrollment

76 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).