Effects of Two Different Online Yoga Interventions on the Quality of Life of Breast Cancer Patients Compared With Waiting List - a Three-arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
研究概览
简要总结
This study investigates the effects of two different online yoga interventions on the health-related quality of life in breast cancer patients. Qualitative and quantitative data will be collected.
详细描述
In this randomized controlled trial breast cancer patients will be randomized into three treatment arms:
- Intervention group 1 will receive an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study mainly includes physical and relaxation exercises.
- Intervention group 2 will receive a meditative yoga intervention online including physical and meditation exercises and also ideologically neutral explanations of the ethical aspects of yoga.
- Group 3 consists of a waiting list control group, combined with the offer to participate in a yoga intervention after 4 months.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of non-metastatic breast cancer (TNM stage I-III) up to 5 years after diagnosis
- •Primary therapy completed for at least 3 months
- •Limitation of the quality of life due to the cancer (indication of at least 4 out of 10 points on the numerical analogue scale)
- •Willingness to participate in the study and signed informed consent.
排除标准
- •Current or planned chemotherapy, radiation or surgery
- •Severe physical or psychopharmacologically treated psychiatric comorbidity due to which a patient is unable to participate in the study
- •Pregnancy/breastfeeding
- •Participation in other clinical trials with behavioral, psychological, or complementary medicine interventions
- •Immobility or limitation for gymnastic exercise due to orthopedic, neurologic, or other medical cause
- •regular meditation practice >2x/month
- •regular yoga practice >2x/month
研究组 & 干预措施
Iyengar yoga
Intervention group 1 receives an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study primarily includes physical and relaxation exercises.
干预措施: Iyengar Yoga (Behavioral)
Meditative yoga
Intervention group 2 receives an Integrative yoga intervention online including physical and meditation exercises as well as ideologically neutral explanations of the ethical aspects of Yoga.
干预措施: Meditative Yoga (Behavioral)
Waitlist Control Group
Group 3 consists of a waitlist control group. Participants will be offered the opportunity to attend a yoga intervention after 4 months. The patients in this waiting list control group are allowed to choose the yoga course after 4 months.
结局指标
主要结局
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
时间窗: Date of inclusion (baseline), after 8 weeks
Assessing full scale, range 0-40, higher score meaning a better outcome
次要结局
- Behavioural question 2(Date of inclusion (baseline))
- Behavioural question 3(Date of inclusion (baseline))
- Behavioural question 4(Date of inclusion (baseline))
- Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Perceived Stress Scale (PSS-10)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Flourishing Scale (FS-D)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Self-Compassion Scale (SCS-D)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Self-Efficacy Scale (ASKU)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Sociodemographic measures(Date of inclusion (baseline))
- Behavioral questions: cigarettes(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Behavioral questions: alcohol(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Expectation question(Date of inclusion (baseline))
- Behavioural question(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Functional Assessment of Cancer Therapy - General (FACT-G)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Yama/Niyama Questionnaire - YaNiQ(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks)
研究者
Andreas Michalsen
Prof. Dr. Andreas Michalsen
Charite University, Berlin, Germany