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

Overview

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.

Interventions

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

Primary outcome measures

• Hot Flash Score (HFS) [Time frame: 28 days]

Secondary outcome measures (5)

• Patient adherence [Time frame: 28 days]
• Score of quality of life [Time frame: 28 days]
• Sleep quality [Time frame: 28 days]
• Patient satisfaction [Time frame: 28 days]
• Usability of the digital tool [Time frame: 28 days]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT06552091 · 2024-A01105-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗