Clinical trial NCT06552091: Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Hormone Therapy
Official title: Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Hormone Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: breast cancer
non-metastatic
hormone therapy
hot flashes
self-hypnosis
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Standard group: standard care.
* Hypnosis group: experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily.
Primary purpose: SUPPORTIVE_CARE

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 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 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).

Primary outcomes:
measure: Hot Flash Score (HFS)
timeFrame: 28 days
Secondary outcomes:
measure: Patient adherence
timeFrame: 28 days
measure: Score of quality of life
timeFrame: 28 days
measure: Sleep quality
timeFrame: 28 days
measure: Patient satisfaction
timeFrame: 28 days
measure: Usability of the digital tool
timeFrame: 28 days
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Boujedaini Naoual
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: AURELIEN AL LAMBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: