Effectiveness of “Healthy Breast-Mind Body Medicine Programâ€(HB-MBMP) in addition to Standard Care in Young Female Breast Cancer patients on Sleep Quality, Circadian rhythm (HPA axis Regulation), QoL in a Tertiary Care Hospital in Rishikesh, Uttarakhand: An Open Label Double-arm Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CCRYN
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Sleep Quality (PSQI)
研究概览
简要总结
Adolescents and young women with breast cancer have special psychosocial issues such as concerns for effects on family life, personal life and career. They face body related stigma, breast feeding related issues, education related issues. (3) Sleep disturbances are common symptoms in individuals with breast cancer. The incidence varies across studies depending on the study design and assessment methods, but most studies have reported that 60%–90% of patients with breast cancer have sleep disturbances—much higher than that in the healthy population. (4)
Yoga has a comprehensive approach towards the mind and body, giving a specific philosophical attitude towards life, with a meditative and attentional component as the basis for all its practices, thus being shown to have many psychophysiological effects, such as reducing anxiety levels and physiologic arousal; improving subjective sleep quality in patients with chronic insomnia; reducing both subjective and objective insomnia symptoms; and improving quality of life. Yoga and meditation are also inexpensive and side-effect–free interventions, which are well tolerated and used as integrative practices in non-drug treatments in many health-related contexts. Its therapeutic potential lies in promoting physical, emotional, and spiritual well-being, making it an attractive option for individuals dealing with the complexities of breast carcinoma. (5)
For holistic health all the five sheaths of our body (Pancha Kosha) namely Annamaya Kosha, Pranamaya Kosha, Manomaya Kosha, Vijyanmaya Kosha and Anandamaya Kosha are to be kept in good condition. Disturbance in one affects the other because these five sheaths function in coordination with each other to form an integral whole. It is important to awaken and strengthen these koshas as they provide the road map to lead us smoothly from our physiological; to psychological to spiritual self and thus help us live a healthy, happy and peaceful life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- Female
入选标准
- •Young women aged 15-39 years’ patients diagnosed with histologically confirmed breast carcinoma with newly diagnosed cases with I – III stages.
- •Patients undergoing active treatment for breast carcinoma, including surgery, chemotherapy, radiation therapy, hormone therapy, or a combination of these treatments.
- •Patients with a ECOG score of 60 or above, indicating a reasonable ability to perform daily activities Patients who can provide informed consent to participate in the study.
排除标准
- •Patients with severe cognitive impairments or mental health conditions that may hinder their ability to participate in yoga sessions or complete study assessments Patients with physical disabilities or musculoskeletal conditions that may prevent them from safely engaging in yoga practices Patients with severe uncontrolled comorbidities (e.g., heart failure, chronic obstructive pulmonary disease) that may limit their ability to participate in yoga safely Patients currently engaged in other mind-body practices or alternative therapies that may confound the study results Patients with a history of prior yoga intervention for breast carcinoma within the past six months Pregnant patients, as yoga practices may need to be modified during pregnancy, and hormonal changes during pregnancy can impact study outcomes Patients not having access to smartphones and Internet connectivity.
结局指标
主要结局
Sleep Quality (PSQI)
时间窗: Day 0, Day 30, 3 month, 6 month/termination of trial
次要结局
- Quality of Life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0)(Day 0, Day 30, 3 month, 6 month/termination of trial)
- Anxiety, Stress and Depression(Day 0, Day 30, 3 month, 6 month/termination of trial)
- Positive and Negative Affect Schedule(Day 0, Day 30, 3 month, 6 month/termination of trial)
- Salivary Cortisol(Day 0, 6 month/termination of trial)
- Salivary DHEA(Day 0, 6 month/termination of trial)
- ACTH(Day 0, 6 month/termination of trial)
- CRH(Day 0, 6 month/termination of trial)
- HRV(Day 0, 6 month/termination of trial)
- Level of Lymphedema(Day 0, 6 month/termination of trial)
研究者
Dr Vartika Saxena and Dr Farhanul Huda
AIIMS, Rishikesh