A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Global Quality of Life scores as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) instrument
研究概览
简要总结
This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.
详细描述
Patients who are eligible and provide informed consent will be enrolled into this single arm study. Patients will be prescribed non-hormonal pharmacotherapy tailored to the timing of their predominant symptoms. They will be given access to an evidence based platform for digital CBT for insomnia and asked to identify a partner or other companion who will commit to providing psychosocial support to the research participant throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Females over 18 years of age at the time of recruitment and onboarding.
- •Vasomotor symptoms of menopause
- •Previous or current cancer diagnosis
- •Conventional menopausal hormone therapy contraindicated for any reason
- •Can speak and read English proficiently
- •Competent using the internet and has access to smartphone or similar device
排除标准
- •ECOG performance status >3
- •Use of study medications to manage menopausal symptoms in the preceding 6 months
- •Use of CBT for insomnia in the preceding 6 months
- •Any contraindication to study medications
- •No internet access or competency issue with internet use
- •Unable to complete questionnaires or give informed consent
- •Current major mental illness
结局指标
主要结局
Global Quality of Life scores as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) instrument
时间窗: 6 months
Global quality of life will be assessed using the EORTC QLQ C30 questionnaire. This is a 30 item questionnaire which has been extensively validated internationally and is specific to patients treated for cancer. Minimum global quality of life score is 0 with a maximum of 100 with a higher score representing a better quality of life.
次要结局
- Bother/Interference of vasomotor symptoms of menopause as measured by the Hot Flush Rating Scale(6 months)
- Sleep dysfunction as measured by the Sleep Condition Indicator(6 months)
研究者
Donal Brennan
Professor of Gynaecological Oncology
University College Dublin