Evaluation of an Ayurvedic Whole Systems-based Lifestyle Protocol for Quality of Breast Cancer Survivorship: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Sleep disturbance
研究概览
简要总结
This study is a pilot study to assess the feasibility and effectiveness of a 12-week intervention of personalized diet and lifestyle protocol based on the principles of Ayurveda's whole systems approach to achieving improvement in a) quality of life, b) digestive health, c) sleep among women breast cancer survivors.
详细描述
Breast cancer is the most common cancer among women worldwide. Due to advancements in early diagnosis and treatment, the survival rate of breast cancer has significantly increased. According to the National Cancer Institute's office of cancer survivorship, as of January 2019, there are 3.8 million breast cancer survivors.
Evidence indicates that cancer survivors experience many adverse effects of treatment and suffer from significant quality of life (QOL) challenges such as depression, anxiety, emotional, social, psychological, physiological, and spiritual wellbeing.
Personalized diet, lifestyle and daily routine approaches to breast cancer survivorship are often undervalued. Generally, the dietary guidelines are based only on an individual's nutritional and caloric needs.
Due to the increasing number of breast cancer survivors, it has become essential to have evidence-based guidelines for breast cancer survivorship to improve digestive health, QOL, and general wellbeing. Understanding the science behind personalized lifestyle-related factors, including diet, exercise, and emotional and spiritual wellbeing in cancer survivorship, is urgently needed. Digestive health and the gut microbiome may play an important role in the QOL after surviving breast cancer; however, there are fewer studies on the relationship between diet and daily routine to gut health and breast cancer survivorship care.
This study will test whether personalized guidelines based on the principles of Maharishi Ayurveda - a whole systems approach to reducing strength, improving digestive health and living in harmony with the circadian rhythm to improve QOL for women diagnosed and treated for breast cancer. In addition to that, this pilot study may provide preliminary data to further develop a clinical practice guideline that is cost-effective and easy to follow for women 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
- Supportive Care
- 盲法
- None
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
- •A breast cancer survivor in remission (Females ≥ 18 years)
- •Diagnosis of stage I-IV breast cancer
- •Three months or more after receiving conventional treatment (chemotherapy, radiation therapy, and/or surgery)
- •Willing to comply with the study intervention recommendations for 12 weeks
- •English speaking
- •Have access to technology to participate in zoom visits
排除标准
- •Male responders
- •Inability to provide informed consent
- •Physiological or psychological debility that would interfere with the ability to participate in the study fully
- •Active metastatic or recurrent disease (to avoid early withdrawal from the study)
- •Anticipates undergoing surgery during the duration of the intervention
- •Substance abuse (to avoid early withdrawal from the study)
结局指标
主要结局
Change in Sleep disturbance
时间窗: 0, 6 weeks and 12 weeks
Assess change from baseline sleep disturbance to 6 and 12 weeks. Researchers will use the following Self-reported outcome measure instruments: Assessment using the General Sleep Disturbance Scale (GSDS).
Change in Quality of life
时间窗: 0, 6 weeks, and 12 weeks
Assess change from baseline quality of life to 6 and 12 weeks. Researchers will use the following Self-reported outcome measure instruments: Quality of life: Quality of Life instrument (cancer patient/cancer survivor version) developed by the City of Hope National Medical Center in California.
Change in Digestive health
时间窗: 0, 6 weeks, and 12 weeks
Assess change from baseline digestive health to 6 and 12 weeks. Researchers will use the following Self-reported outcome measure instruments: Ayurvedic assessment of digestive strength questionnaire and Gastrointestinal Symptoms Rating Scale (GSRS) for the gut health assessment.
次要结局
未报告次要终点
研究者
Robert Schneider, MD
Director, Institute for Natural Medicine and Prevention; Dean, College of Integrative Medicine
Maharishi International University