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

NCT ID: NCT05743023

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-06-01

Brief 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.

Conditions

Breast Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Consciousness-based Ayurvedic lifestyle Intervention

In the intervention group, each participant will receive a structured education and be asked to follow a 12-week personalized diet and daily routine protocol based on the assessment of their current Ayurvedic mind-body state. Participants will be asked to complete the self-reported questionnaires at baseline, 6, and 12-week.

Group Type: EXPERIMENTAL

Ayurvedic lifestyle protocol

Intervention Type: BEHAVIORAL

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.

Waitlist control

Participants in the waitlist control group will not receive any intervention. They will continue usual care and will be asked to complete the self-reported questionnaires at baseline, 6, and 12-week. Participants n this group receive their personalized protocol at the end of 12 weeks after completing all the data collection.

Group Type: ACTIVE_COMPARATOR

Ayurvedic lifestyle protocol

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

personalized diet and daily routine protocol

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Robert Schneider, MD

OTHER

Sponsor Role: lead

Responsible Party

Robert Schneider, MD

Director, Institute for Natural Medicine and Prevention; Dean, College of Integrative Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Schneider, MD

Role: PRINCIPAL_INVESTIGATOR

Maharishi International University, Fairfield, Iowa

Locations

Maharishi International University

Richmond, California, United States

Countries

United States

Other Identifiers

07102022_SR

Identifier Type: -

Identifier Source: org_study_id