Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

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.

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.

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.

Ayurvedic lifestyle protocol

Robert Schneider, MD

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.

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

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

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.

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.

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).

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

All participants will be in the health coaching group. Participants on study will receive a health coach for 6 months.

6 months of integrative health coaching, goal setting, survey administration and physical assessments.

Health Coaching

Brianna Castrogivanni, MS

Carly Bailey, MA

William Wood, MD

William A Wood, MD, MPH

Purpose: The HealthScore Health Coaching Program aims to deliver 6-months of 1:1 home-based health coaching to cancer patients receiving treatment and survivors of any diagnosis at UNC Cancer Hospital. This study hopes to preserve physical function, address unmet physical, nutritional, psychological, social and other needs.

Procedures: This will be done through individualized health coaching, weekly symptom survey administration, monthly supportive care questionnaires, and physical assessments at baseline, 3 months and 6 months.

Participants: All cancer patients with appointments at UNC Cancer Hospitals.

Evaluation and monitoring are used sporadically in routine cancer care, and cancer coaching programs are rare. The potential for these approaches to improve quality of life and clinical outcomes in cancer patients is significant. The HealthScore Health Coaching Program is designed as a way to routinely combine evaluation, monitoring and coaching within a single framework as a six-month intervention for cancer patients or survivors. The primary rationale for the Program is that improvements in physical function, unmet needs identification, and self-efficacy are likely to lead to better patient-centered and overall outcomes for patients and survivors. A secondary rationale is that the framework of the Program and data obtained as part of the Program will facilitate additional quality improvement and research activities to refine the application of evaluation, monitoring and coaching techniques in cancer care. As reimbursement and care delivery in oncology transition to a focus on value and population-based management, the HealthScore Health Coaching Program may provide a model for application to cancer care within and outside UNC. The primary purpose of this study is to provide 6-months of 1:1 home-based health coaching for cancer patients and survivors will improve physical function and address unmet physical, nutritional, psychological, social and other needs which will increase patient and survivor self-efficacy for medical engagement, reduce morbidity, health care utilization, and encourage health lifestyle behaviors.

The HealthScore Health Coaching Program

To provide health coaching services for cancer patients and survivors at UNC through the HealthScore Program, measured by calculating numbers of participants enrolled and completing the six-month HealthScore health coaching intervention each year.

Change in PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function 8b on a scale of 0-60.5. Higher scores indicate better physical function.

Percentage of possible coaching phone calls completed

Percentage of possible patient-reported surveys completed

Percentage of possible days using the wearable sensor with evaluable data

Number of unmet needs addressed while participating in health coaching

Magnitude of change in self-efficacy during program participation using the Lorgis Self-efficacy scale. The score is the mean of six items, scored 0-10. Higher scores are better.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Consciousness-based Ayurveda Lifestyle Program for Improving Quality of Life in Survivors of Breast Cancer	NCT05743023	Breast Cancer S...	Ayurvedic lifes...	18 Years -	Maharishi International University
Consciousness-based Ayurveda Lifestyle Program for Improving Quality of Life in Survivors of Breast Cancer	NCT05743023	Breast Cancer S...	Ayurvedic lifes...	18 Years -	Maharishi International University
The HealthScore Health Coaching Program	NCT04923997	Cancer Survivorship Quality of Life Health Behavior	Health Coaching	15 Years -	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for integrative

Every month we try and update this database with for integrative cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for integrative

Every month we try and update this database with for integrative cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for integrative cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.