Guided Digital Self-Hypnosis Solution for Managing Hot Flashes in Patients Undergoing Adjuvant Hormone Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Hot Flash Score (HFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient,
- •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.
排除标准
- •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).
研究组 & 干预措施
Standard group
standard care
Hypnosis group
experimental care with 3 self-hypnosis sessions over 3 weeks, one session per week to be practiced daily
干预措施: self-hypnosis sessions (Other)
结局指标
主要结局
Hot Flash Score (HFS)
时间窗: 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.
次要结局
- Patient satisfaction(28 days)
- Patient adherence(28 days)
- Sleep quality(28 days)
- Score of quality of life(28 days)
- Usability of the digital tool(28 days)