Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Menopausal symptoms
研究概览
简要总结
This randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.
详细描述
Breast cancer patients undergoing endocrine therapy are often suffering from side effects. This randomized controlled trial analyzes the effects of an 11-week day care clinic group program including mind body medical elements (yoga, relaxation, meditation, education) and acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosed breast cancer (Stage I-III), no metastases
- •Current endocrine therapy (minimum 3 months)
- •Score of 9 or greater on the Menopausal Rating Scale (MRS)
- •Signed informed consent
排除标准
- •Severe other somatic or psychiatric comorbidity
- •Pregnancy
- •Planned or existing chemotherapy, radiation or other cure treatment
- •Participation in other clinical studies with behaviour-oriented, psychological or compementary medicine intervention.
研究组 & 干预措施
Mind body medicine day care clinic
Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education
干预措施: Mind body medicine day care clinic (Behavioral)
Usual care
Patients continue usual care by their practitioner
干预措施: Usual care (Other)
结局指标
主要结局
Menopausal symptoms
时间窗: week 11
Menopause Rating Scale (MRS)
次要结局
- Stress(week 23)
- Compliance(week 23)
- Menopausal smptoms(week 23)
- Adverse Events(week 23)
- General health-related quality of life(week 11)
- Mental wellbeing(week 23)
- Adverse events(week 11)
- Spiritual health-related quality of life(week 23)
- Fatigue(week 23)
- Genaeral health-related quality of life(week 23)
- Spiritual health-related quality of life(week 11)
- Fatigue(week 11)
- Mental wellbeing(week 11)
- Stress(week 11)
- Compliance(week 11)
研究者
Heidemarie Haller
Postdoctoral Research Fellow
Universität Duisburg-Essen