Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06552091

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

Led by Institut de Cancérologie de Lorraine · Updated on 2026-02-17

76

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient
  • WHO performance status 2 or less
  • Premenopausal, perimenopausal, or postmenopausal at diagnosis
  • Treated for non-metastatic breast cancer
  • Receiving ongoing adjuvant endocrine therapy, with or without anti-CDK 4/6 targeted therapy
  • Experiencing at least 50 hot flashes per week or at least 7 hot flashes per day
  • Has a computer device capable of accessing the self-hypnosis program
  • Provided informed consent
  • Affiliated with the social security system
Not Eligible

You will not qualify if you...

  • Male
  • Hearing impairments
  • Psychotic or cognitive disorders as assessed by clinician
  • Does not understand French
  • Not diagnosed with non-metastatic breast cancer
  • Not undergoing anti-aromatase treatment
  • Fewer than 50 hot flashes per week or fewer than 7 hot flashes per day
  • Previous participation in hypnosis or self-hypnosis program
  • Currently in a therapeutic program for hot flashes
  • Already enrolled in another therapeutic trial on the same topic
  • Already enrolled in another therapeutic trial with experimental drug
  • Pregnant or breastfeeding
  • Deprived of liberty including guardianship or curatorship

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

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Research Team

J

JEAN LOUIS MERLIN, PUPH

CONTACT

C

CECILE HUIN SCHOHN, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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