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

NCT ID: NCT06552091

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2027-02-17

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.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard group

standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hypnosis group

experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily

Group Type: EXPERIMENTAL

self-hypnosis sessions

Intervention Type: OTHER

3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily

Interventions

self-hypnosis sessions

3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AURELIEN LAMBERT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

JEAN LOUIS MERLIN, PUPH

Role: CONTACT

jl.merlin@nancy.unicancer.fr

+33 3 83 65 60 62

CECILE HUIN SCHOHN, PhD

Role: CONTACT

c.huinschohn@nancy.unicancer.fr

+ 33 3 83 59 86 07

Facility Contacts

JEAN LOUIS MERLIN, PU-PH

Role: primary

jl.merlin@nancy.unicancer.fr

+33 3 83 65 60 62

CECILE HUIN SCHOHN, PhD

Role: backup

c.huinschohn@nancy.unicancer.fr

+ 33 3 83 59 86 07

Other Identifiers

2024-A01105-42

Identifier Type: -

Identifier Source: org_study_id