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

NCT05743023 | Unknown

• 1 other identifier: 07102022_SR
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivors

Keywords

Breast cancer; Breast cancer survivorship; Ayurveda; Lifestyle; Integrative; Mind-body medicine

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Consciousness-based Ayurvedic lifestyle Intervention

EXPERIMENTAL

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.

Behavioral: Ayurvedic lifestyle protocol

Waitlist control

ACTIVE COMPARATOR

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.

Behavioral: Ayurvedic lifestyle protocol

Interventions

Ayurvedic lifestyle protocol 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.

Also known as: personalized diet and daily routine protocol

Consciousness-based Ayurvedic lifestyle Intervention; Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Robert Schneider, MD: lead

Study Sites (1)

Maharishi International University

Richmond, California, 94806, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Schneider, MD

  Maharishi International University, Fairfield, Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Institute for Natural Medicine and Prevention; Dean, College of Integrative Medicine

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: February 24, 2023
• Study Start: September 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)