Breast Cancer SurvivorsNCT05743023
Consciousness-based Ayurveda Lifestyle Program for Improving Quality of Life in Survivors of Breast Cancer
A study testing Ayurvedic lifestyle protocol in people with Breast Cancer Survivors, run by Robert Schneider, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Ayurvedic lifestyle protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Maharishi International University
Richmond, California, 94806
About this study
Official title: Evaluation of an Ayurvedic Whole Systems-based Lifestyle Protocol for Quality of Breast Cancer Survivorship: A Randomized Controlled Pilot Study
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.
Read the 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
- Being tested
- Ayurvedic lifestyle protocol
- Keywords
- Breast cancer, Breast cancer survivorship, Ayurveda, Lifestyle, Integrative, Mind-body medicine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayurvedic lifestyle protocolBehavioural
Also called personalized diet and daily routine 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Ayurvedic lifestyle protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 0, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Sep 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Schneider, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Schneider, MD, Maharishi International University
- Investigators
- Robert Schneider, MD, Principal investigator, Maharishi International University, Fairfield, Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743023
- Sponsor's protocol ID
- 07102022_SR
- Status last verified
- Feb 2023
- First submitted
- 25 Oct 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Ayurvedic Whole Systems-based Lifestyle Protocol for Quality of Breast Cancer Survivorship: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05743023
- Acronym / sponsor ID
- 07102022_SR
- Conditions
- Breast Cancer Survivors
- Keywords
- Breast cancer, Breast cancer survivorship, Ayurveda, Lifestyle, Integrative, Mind-body medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Robert Schneider, MDUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consciousness-based Ayurvedic lifestyle Intervention | Experimental | Behavioral: Ayurvedic lifestyle protocolIn 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. |
| Waitlist control | Active comparator | Behavioral: Ayurvedic lifestyle protocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ayurvedic lifestyle protocolAlso: personalized diet and daily routine protocolBased 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. | Behavioural | Consciousness-based Ayurvedic lifestyle Intervention, Waitlist control |
Primary outcome
Change in Quality of life
Time frame: 0, 6 weeks, and 12 weeks
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.
Change in Digestive health
Time frame: 0, 6 weeks, and 12 weeks
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.
Change in Sleep disturbance
Time frame: 0, 6 weeks and 12 weeks
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Schneider, MD principal investigator
Maharishi International University, Fairfield, Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayurvedic lifestyle protocol in people with Breast Cancer Survivors, run by Robert Schneider, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life (time frame: 0, 6 weeks, and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.