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

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

NCT ID: NCT05743023

Condition: Breast Cancer Survivors

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast cancer
Breast cancer survivorship
Ayurveda
Lifestyle
Integrative
Mind-body medicine

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Ayurvedic lifestyle protocol
Description: 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.
Arm group label: Consciousness-based Ayurvedic lifestyle Intervention
Arm group label: Waitlist control

Other name: personalized diet and daily routine protocol

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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)

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Maharishi International University

Address:
City: Richmond
Zip: 94806
Country: United States

Start date: September 1, 2022

Completion date: June 1, 2023

Lead sponsor:
Agency: Robert Schneider, MD
Agency class: Other

Source: Maharishi International University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05743023