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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Boujedaini Naoual
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
NAOUAL NB BOUJEDAINI, PhD
n.boujedaini@nancy.unicancer.fr
03 83 59 86 68
Backup
CECILE CHS HUIN SCHOHN, PhD
c.huinschohn@nancy.unicancer.fr
03 83 59 86 07
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2027-02-17
Participants
Target number of participants: 76
Treatments
No_intervention: Standard group
standard care
Experimental: Hypnosis group
experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily
Related Therapeutic Areas
Sponsors
Leads: Institut de Cancérologie de Lorraine

This content was sourced from clinicaltrials.gov

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