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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Based on each participant's current mind-body imbalance determination, a personalized 12-week intervention lifestyle protocol will be given. Each protocol will mainly address diet and daily routine, quality of food, food combinations, and living in harmony with natural rhythm for balancing the predominant imbalance based on Ayurvedic principles. In addition, the lifestyle protocol will also include stress-reducing methods and more specifically, participants will be recommended to learn and practice the Transcendental Meditation technique.
Maharishi International University
Richmond, California, United States
Change in Quality of life
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.
Time frame: 0, 6 weeks, and 12 weeks
Change in Digestive health
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.
Time frame: 0, 6 weeks, and 12 weeks
Change in Sleep disturbance
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).
Time frame: 0, 6 weeks and 12 weeks
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