Digitally Distributed Yoga Intervention for Women Treated for Breast Cancer: Effects on Fatigue, Systemic Inflammation and Levels of Activity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 229
- 试验地点
- 6
- 主要终点
- Change in Cancer related fatigue
研究概览
简要总结
Breast cancer is the most common cancer disease in women. As the prevalence of fatigue is high in this group it is motivated to find interventions that can reduce fatigue and render in an increased level of physical activity both during and after treatment. Yoga have shown effect on cancer related fatigue (CRF) and is a rehabilitation activity that is often requested by breast cancer patients. Breast cancer patients live in cites and small-towns as well as in rural areas and therefore there is a need for accessible rehabilitation activities for all patients despite place of residence.
A digitally distributed yoga class can potentially increase accessibility for those living in rural areas.
Aim
The overarching aim of this study is to investigate the effect of a 12-weeks digitally distributed yoga intervention for women treated for breastcancer, compared with a control group receiving regular care, concerning:
- patient reported outcomes, primary endpoint CRF
- systemic inflammation
- activity level
The study will evaluate if there are differences during and after the intervention and if those differences are sustained after 1, 3, 6, 12 and 24 months after the intervention.
Additional objectives are to compare the two groups concerning completing oncologic treatment, cost effectiveness, return to work and also to describe the patients experiences of participating in a digitally distributed yoga class at home.
Research questions
If and how a digitally distributed yoga can influence cancer related fatigue, stress, health related quality of life and level of physical activity compared to regular care? If and how a digitally distributed yoga can have an effect on systemic inflammation? How is the feasibility of digitally distributed yoga twice weekly at home? What is the breast cancer patients' experience of participating in digitally distributed yoga clas?
详细描述
Study design and Setting
This is a randomized controlled multi center study where the participant are randomized to a 12-weeks internet based yoga intervention or regular care. Usual care includes standardized information about the importance of physical activity in their personal care plan.
Three regions located in the middle of Sweden is reqruiting participants and two moore is in the process of starting reqruitment.
From January 2022 permission to reqruit through social media and direct adverticement began, after permission was granted from the ethical board.
Inclusion criteria: Adult women diagnosed with breast cancer, that have undergone breast cancer surgery within 60 days with curative intention, without any signs of metastatic disease, and before start of chemotherapy. They should be Swedish speaking and literate.
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
- Single (Outcomes Assessor)
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
- •Clinical diagnosed with breast cancer Adult women Must have undergone breast cancer surgery with curative intention Must be Swedish speaking Must be able to read
排除标准
- •Metastatic disease Received neoadjuvant treatment before surgery Advanced recurrent disease Unstable cardiovascular disease Brain or bone metastasis Unstable medical condition that might be aggravated by yoga.
结局指标
主要结局
Change in Cancer related fatigue
时间窗: Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery
The Multidimensional Fatigue inventory (MFI) is a 20-item self-reported questionnaire including 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation is a state of physical, emotional, cognitive tiredness or exhaustion related to cancer. The score can be between 20 and 100. Higher score indicate higher fatigue.
次要结局
- Change in Stress(Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery)
- Change in Quality of life(Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery)
- Change in Health related Quality of Life (HRQoL)(Baseline is 1 months after surgery and change after 3, 6, 24 and 48 months after breast cancer surgery)