Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Anti-Aromatase Hormone Therapy
NCT Number: NCT06552091
Acronym: HYBOU
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer Female
Interventions: OTHER: self-hypnosis sessions
Sponsor: Institut de Cancérologie de Lorraine
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-15
Completion Date: 2027-01-15
Locations: Boujedaini Naoual, Vandœuvre-lès-Nancy, 54500, France

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.

Primary Outcome Measures: 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 Outcome Measures: Patient adherence, calculated from the data automatically recorded by the digital solution software. Adherence is thus evaluated by the rate of session follow-ups, estimated by the proportion of patients who followed all the recommended sessions without interruption, for the hypnosis group only., 28 days|Score of quality of life, Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at Day 0 and Day 28. The global score ranges from 0 to 100. For each question the scale ranges from 0 = not at all to 4 = a lot., 28 days|Sleep quality, Evaluated using the Pittsburgh Sleep Quality Index questionnaire score at Day 0 and Day 28. The global score ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties., 28 days|Patient satisfaction, Assessed at Day 28 using a numerical scale. The numerical scale ranges from 0 = not satisfied to 10 = very satisfied., 28 days|Usability of the digital tool, Assessed at Day 28 using the System Usability Scale questionnaire score (Gronier \& Baudet, 2021) for the hypnosis group only. It's composed of 10 questions on a scale from 0 = strongly disagree to 5 = strongly agree, 28 days