Consciousness-based Ayurveda Lifestyle Program for Improving Quality of Life in Survivors of Breast Cancer

Breast Cancer Survivors Clinical Trial

Official title:

Evaluation of an Ayurvedic Whole Systems-based Lifestyle Protocol for Quality of Breast Cancer Survivorship: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05743023
• Other study ID #: 07102022_SR
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2023
• Source: Maharishi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms

Intervention

Behavioral:
• Ayurvedic lifestyle protocol
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.

Locations

Country	Name	City	State
United States	Maharishi International University	Richmond	California

Sponsors (1)

Lead Sponsor	Collaborator
Robert Schneider, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0, 6 weeks, and 12 weeks
Primary	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.	0, 6 weeks, and 12 weeks
Primary	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).	0, 6 weeks and 12 weeks