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

NCT06552091 | Recruiting

• 1 other identifier: 2024-A01105-42
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; non-metastatic; hormone therapy; hot flashes; self-hypnosis

Outcome Measures

Primary Outcomes (1)

• Hot Flash Score (HFS)

  In each group (standard and hypnosis), hot flashes will be primarily assessed using the Hot Flash Score (HFS) \[Elkins et al. 2013\], calculated through daily measurements as follows: HFS = frequency × average severity of hot flashes, where severity is rated from 1 to 4 (1: mild, 2: moderate, 3: severe, 4: very severe). The weekly HFS is calculated by averaging the daily HFS scores for each patient. Secondly, we will also evaluate the effect of guided self-hypnosis in reducing the frequency of hot flashes.

  28 days

Secondary Outcomes (5)

• Patient adherence

  28 days

• Score of quality of life

  28 days

• Sleep quality

  28 days

• Patient satisfaction

  28 days

• Usability of the digital tool

  28 days

Study Arms (2)

Standard group

NO INTERVENTION

standard care

Hypnosis group

EXPERIMENTAL

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

Other: self-hypnosis sessions

Interventions

self-hypnosis sessions OTHER

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

Hypnosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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).

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• AURELIEN LAMBERT, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JEAN LOUIS MERLIN, PUPH

CONTACT

+33 3 83 65 60 62; jl.merlin@nancy.unicancer.fr

CECILE HUIN SCHOHN, PhD

CONTACT

+ 33 3 83 59 86 07; c.huinschohn@nancy.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Standard group: standard care. * Hypnosis group: experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 13, 2024
• Study Start: October 17, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): February 17, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-11

Locations

FR (1)