Randomized Controlled Trial of Yoga for Menopausal Symptoms in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Menopausal symptoms
研究概览
简要总结
Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer (Stage I-III)
- •After completion of surgical therapy
- •After completion of adjuvant radiotherapy and chemotherapy
- •Score of 5 or greater on the Menopausal Rating Scale
- •Physical and cognitive capacity to participate in the yoga intervention
- •Willingness to participate in 10 or more of the 12 yoga interventions
- •signed informed consent
排除标准
- •Regular yoga practice in the past 12 months
- •Planned surgery in the study period
- •Diagnosed and medically treated psychosis
- •Hormone replacement therapy
研究组 & 干预措施
Yoga
Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation
干预措施: Yoga (Behavioral)
Yoga
Yoga intervention 12 weeks, weekly 90-minute intervention Yoga postures, breathing, relaxation, and meditation
干预措施: Usual care (Other)
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 12
Menopause Rating Scale
次要结局
- Anxiety(Week 24)
- Health-related quality of life (disease-specific)(Week 24)
- Depression(Week 24)
- Menopausal symptoms(Week 24)
- Adverse events(Week 24)
- Fatigue(Week 24)
- Anxiety(Week 12)
- Depression(Week 12)
- Adverse events(Week 12)
- Fatigue(Week 12)
- Health-related quality of life (disease-specific)(Week 12)
研究者
Holger Cramer
Research Fellow
Universität Duisburg-Essen