Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Hormone Therapy
- Conditions
- Breast Cancer Female
- Interventions
- Other: self-hypnosis sessions
- Registration Number
- NCT06552091
- Lead Sponsor
- Institut de Cancérologie de Lorraine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 76
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypnosis group self-hypnosis sessions experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily
- Primary Outcome Measures
Name Time Method Hot Flash Score (HFS) 28 days 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.
- Secondary Outcome Measures
Name Time Method Patient satisfaction 28 days Assessed at Day 28 using a numerical scale. The numerical scale ranges from 0 = not satisfied to 10 = very satisfied.
Patient adherence 28 days 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.
Sleep quality 28 days 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.
Score of quality of life 28 days 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.
Usability of the digital tool 28 days 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
Trial Locations
- Locations (1)
Boujedaini Naoual
🇫🇷Vandœuvre-lès-Nancy, France