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

Study acronym: HYBOU
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later across 2 updates Apr 30, 2026 → Sep 20, 2027
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Record History

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  1. Notable Start date: Oct 17, 2024 to Dec 20, 2024 Show 4 more changesShow less
    • Primary completion pushed from Apr 30, 2027 to Sep 20, 2027
    • Study completion pushed from Feb 17, 2028 to Sep 2028
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 5 of 5 entries
  2. Notable Primary completion pushed from Apr 30, 2026 to Apr 30, 2027
    • Study completion pushed from Feb 17, 2027 to Feb 17, 2028
    v7
  3. Minor Study title expanded, about 1 wordv6
  4. Minor Study site revisedv5
  5. Notable Primary completion date: Mar 15, 2025 to Apr 30, 2026
    • Study completion date: Jan 15, 2027 to Feb 17, 2027
    • Eligibility criteria expanded, about 38 words
    • Study title shortened, about 1 word
    v4
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  1. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v3
  2. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Sep 15, 2024 to Oct 17, 2024
    • Site contact updated
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06552091
Lead Sponsor Institut de Cancérologie de Lorraine
Conditions
(from sponsor)
Breast Cancer Female
Related terms Breast Neoplasms, Hot Flashes
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov