Role of mindfulness based intervention on behavioral and inflammatory parameters in breast cancer survivors in Eastern India: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- perceived stress and depression: PPS (Perceived Stress Scale) and
研究概览
简要总结
Breast cancer is one of the most common cancer in our country. The survivors often suffer from pain, fatigue, stress, anxiety, inability to cope up with the disease etc. There is paucity of literature regarding benefits of mindfulness based intervention: MBI in this subgroup. MBI is an evidence based intervention with established role in various chronic diseases like diabetes, polyneuropathies, chronic pain conditions etc. It emphasises participants to pay attention to the situation in a compassionate and non judgemental manner. Though there have been studies on breast cancer survivors in Western world, data is lacking in India. hence, this study aims to determine to feasibility and benefits of MBI on psychological, behavioural and biochemical parameters of breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Breast cancer survivors stage 0 to IIIa who would have completed cancer treatment within the past 3 years (except for tamoxifen/aromatase inhibitors).
- •They should be at least 2 months postsurgery or adjuvant therapy or radiation, whichever occurred later.
排除标准
- •â€“Exclusion criteria would be patients on active therapy, inflammatory breast cancer, anemia, diabetes, chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease, conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse, current yoga practice (within the last 6 months), and/or previous yoga practice for more than 3 months.
- •Women reporting 5 hours or more of vigorous physical activity per week will also be excluded.
结局指标
主要结局
perceived stress and depression: PPS (Perceived Stress Scale) and
时间窗: baseline, 6 weeks, 3 months
HADS
时间窗: baseline, 6 weeks, 3 months
次要结局
- Effect on inflammatory markers: IL-6, interleukin-1 beta , C reactive protein and human TNF(Effect on serum cortisol levels.1)