Breast CancerNCT00508794
Effects of Yoga in Breast Cancer Patients
A study testing Yoga Group and Questionnaire in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Yoga Group and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2006to 11 Aug 2022
- 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
- Women with Stage 0 - III breast cancer, undergoing daily adjuvant radiation for 6 weeks in the Department of Radiation Oncology at the M. D. Anderson
- The participants will need to be 18 years of age or older.
- Patients should be able to read, write, and speak English or Spanish.
Who cannot join
- Patients who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- Patients with metastatic disease of the bone will be excluded to avoid any bone fractures that may result from yoga movements.
- Patients with active/non-canalized deep vein thrombosis will be excluded from the study.
- Patients who have not undergone any surgical treatment for their cancer will be excluded to ensure a more homogeneous sample.
- Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted) will be excluded.
- Patients who have practiced yoga or taken yoga classes in the year prior to diagnosis will be excluded.
- Patients diagnosed with lymphedema at baseline will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Biobehavioral Effects of Yoga During Breast Cancer Treatment
In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective.
Our specific aims in the proposed study are to:
- Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
- Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).
- Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.
Read the detailed description
If you choose to take part in this study, you will come to M. D. Anderson for your first visit. If this is not convenient, a researcher can visit you at your home. At this time, you will be asked to complete several questionnaires. The questions will ask about your sleeping habits, how you have been feeling, and your general QOL. This will take about 45-60 minutes to complete. Researchers, will then ask you to complete a daily sleep diary for the next 7 days. During this time, you will be given an actigraph watch to wear that will collect data about your day-time activity and sleeping habits. The watch should be worn 24 hours a day for 7 days a week. You will have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) and your breathing rate will be measured.
After your first visit to M. D. Anderson or after a researcher has visited you at home, you will be randomly assigned (as in the toss of a coin) to one of 3 groups.
Participants in the first group will take part in a yoga program. If you are assigned to the yoga group, you will take part in 3 sessions of yoga each week for 6 weeks. You may take part in the yoga sessions any 3 days of the week. Each yoga session will last around 60 minutes. During the yoga sessions, you will also be asked to do breathing exercises and to perform different movements and meditation. None of the movements are difficult. You will be able to follow this program at your own pace.
Participants in the second group will take part in a stretching program. If you are assigned to the stretching group, you will take part in 3 sessions of stretching each week for 6 weeks. You may take part in the stretching sessions any 3 days of the week. Each stretching session will last around 60 minutes. During these stretching sessions you will be asked to do simple stretching exercises. None of the movements are difficult. You will be able to follow this program at your own pace.
Beginning with the second week, participants in the first and second groups will be asked to complete a brief questionnaire, about the yoga or stretching program, before the first class each week. The questionnaire will take about 1 to 2 minutes to complete. You will also have an ECG and your breathing rate will be measured before and after one of the classes during the third or fourth week and again during the last week. Each stretching and yoga session will be audio and video taped for the purpose of quality control.
Participants in the third group will not take part in the yoga or stretching program during this study. However, if you are assigned to this group, you will be given the option of participating in the yoga or stretching program after the study has ended. This will be after you have finished your last assessment.
All participants will complete a brief questionnaire during the middle of radiotherapy. The questionnaire will evaluate your treatment-related symptoms and will take about 15 minutes to complete.
During the last week of radiotherapy, and at 1, 3, and 6 months after the end of radiation treatment, all participants will be asked to fill out a packet of questionnaires (similar to those taken at the first visit). It should take about 45 minutes to complete all of the questionnaires. If it is not convenient for you to come to M. D. Anderson, a researcher can visit you at home to help with the questionnaires. You will then be asked to complete another daily sleep diary for another 7 days. During this time, you will wear an actigraph watch 24 hours a day for 7 days a week to collect the same data as before. During this time, you will have an ECG and your breathing rate will be measured.
All participants will be asked to refrain from participating in any other yoga classes for the duration of the study.
Your participation in this study will be over after your 6-month assessment.
This is an investigational study. Up to 180 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Yoga Group, Stretching Control Group, Waitlist Control Group, Questionnaire
- Keywords
- Breast Cancer, Tibetan Yoga, Stretching Program, Yoga, Quality of Life, Questionnaire, Survey
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga GroupBehavioural
3 sessions of yoga each week for 6 weeks.
Stretching Control GroupBehavioural
3 sessions of stretching each week for 6 weeks
Waitlist Control GroupBehavioural
Option of participating in the yoga or stretching program after the study has ended.
QuestionnaireOther
Also called Survey
Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Yoga Program | Experimental | 3 sessions of yoga each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy. Receives: Behavioral: Yoga Group; Other: Questionnaire |
| Group 2 Stretching Program | Experimental | 3 sessions of stretching each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy. Receives: Behavioral: Stretching Control Group; Other: Questionnaire |
| Group 3 Waitlist Control Group | Other | Option of participating in the yoga or stretching program after the study has ended. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy. Receives: Behavioral: Waitlist Control Group; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue and sleep assessed with self-report measures and actigraphy.
Measured: Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session.
Secondary outcomes (2)
To see if yoga will help to improve patients' quality of life (QOL) during treatment for cancer and during recovery from the effects of cancer treatment.
Measured: 4 Years
To learn if a yoga program is effective in helping to decrease emotional distress and improve physiological functioning.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study start9 Mar 2006
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508794
- Sponsor's protocol ID
- 2005-0522
- Other IDs
- CA102385, NCI-2010-00743
- Status last verified
- Aug 2022
- First submitted
- 27 Jul 2007
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Effects of Yoga During Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT00508794
- Acronym / sponsor ID
- 2005-0522
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Tibetan Yoga, Stretching Program, Yoga, Quality of Life, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 9 Mar 2006 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 30 Jul 2007 (estimated)
- 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.
In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective.
Our specific aims in the proposed study are to:
- Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
- Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).
- Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.
Detailed description
If you choose to take part in this study, you will come to M. D. Anderson for your first visit. If this is not convenient, a researcher can visit you at your home. At this time, you will be asked to complete several questionnaires. The questions will ask about your sleeping habits, how you have been feeling, and your general QOL. This will take about 45-60 minutes to complete. Researchers, will then ask you to complete a daily sleep diary for the next 7 days. During this time, you will be given an actigraph watch to wear that will collect data about your day-time activity and sleeping habits. The watch should be worn 24 hours a day for 7 days a week. You will have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) and your breathing rate will be measured.
After your first visit to M. D. Anderson or after a researcher has visited you at home, you will be randomly assigned (as in the toss of a coin) to one of 3 groups.
Participants in the first group will take part in a yoga program. If you are assigned to the yoga group, you will take part in 3 sessions of yoga each week for 6 weeks. You may take part in the yoga sessions any 3 days of the week. Each yoga session will last around 60 minutes. During the yoga sessions, you will also be asked to do breathing exercises and to perform different movements and meditation. None of the movements are difficult. You will be able to follow this program at your own pace.
Participants in the second group will take part in a stretching program. If you are assigned to the stretching group, you will take part in 3 sessions of stretching each week for 6 weeks. You may take part in the stretching sessions any 3 days of the week. Each stretching session will last around 60 minutes. During these stretching sessions you will be asked to do simple stretching exercises. None of the movements are difficult. You will be able to follow this program at your own pace.
Beginning with the second week, participants in the first and second groups will be asked to complete a brief questionnaire, about the yoga or stretching program, before the first class each week. The questionnaire will take about 1 to 2 minutes to complete. You will also have an ECG and your breathing rate will be measured before and after one of the classes during the third or fourth week and again during the last week. Each stretching and yoga session will be audio and video taped for the purpose of quality control.
Participants in the third group will not take part in the yoga or stretching program during this study. However, if you are assigned to this group, you will be given the option of participating in the yoga or stretching program after the study has ended. This will be after you have finished your last assessment.
All participants will complete a brief questionnaire during the middle of radiotherapy. The questionnaire will evaluate your treatment-related symptoms and will take about 15 minutes to complete.
During the last week of radiotherapy, and at 1, 3, and 6 months after the end of radiation treatment, all participants will be asked to fill out a packet of questionnaires (similar to those taken at the first visit). It should take about 45 minutes to complete all of the questionnaires. If it is not convenient for you to come to M. D. Anderson, a researcher can visit you at home to help with the questionnaires. You will then be asked to complete another daily sleep diary for another 7 days. During this time, you will wear an actigraph watch 24 hours a day for 7 days a week to collect the same data as before. During this time, you will have an ECG and your breathing rate will be measured.
All participants will be asked to refrain from participating in any other yoga classes for the duration of the study.
Your participation in this study will be over after your 6-month assessment.
This is an investigational study. Up to 180 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Yoga Program | Experimental | Behavioral: Yoga Group, Other: Questionnaire3 sessions of yoga each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy. |
| Group 2 Stretching Program | Experimental | Behavioral: Stretching Control Group, Other: Questionnaire3 sessions of stretching each week for 6 weeks. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy. |
| Group 3 Waitlist Control Group | Other | Behavioral: Waitlist Control Group, Other: QuestionnaireOption of participating in the yoga or stretching program after the study has ended. Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with Stage 0 - III breast cancer, undergoing daily adjuvant radiation for 6 weeks in the Department of Radiation Oncology at the M. D. Anderson
- The participants will need to be 18 years of age or older.
- Patients should be able to read, write, and speak English or Spanish.
Key exclusion criteria (7 listed)
- Patients who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- Patients with metastatic disease of the bone will be excluded to avoid any bone fractures that may result from yoga movements.
- Patients with active/non-canalized deep vein thrombosis will be excluded from the study.
- Patients who have not undergone any surgical treatment for their cancer will be excluded to ensure a more homogeneous sample.
- Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted) will be excluded.
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 |
|---|---|---|
| Yoga Group3 sessions of yoga each week for 6 weeks. | Behavioural | Group 1 Yoga Program |
| Stretching Control Group3 sessions of stretching each week for 6 weeks | Behavioural | Group 2 Stretching Program |
| Waitlist Control GroupOption of participating in the yoga or stretching program after the study has ended. | Behavioural | Group 3 Waitlist Control Group |
| QuestionnaireAlso: SurveyQuestionnaire evaluating treatment-related symptoms during the middle of radiotherapy. | Other | Group 1 Yoga Program, Group 2 Stretching Program, Group 3 Waitlist Control Group |
Primary outcome
Fatigue and sleep assessed with self-report measures and actigraphy.
Time frame: Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session.
2 secondary outcomes
To see if yoga will help to improve patients' quality of life (QOL) during treatment for cancer and during recovery from the effects of cancer treatment.
Time frame: 4 Years
To learn if a yoga program is effective in helping to decrease emotional distress and improve physiological functioning.
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Lorenzo Cohen, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Group and Questionnaire in people with Breast Cancer, run by M.D. Anderson Cancer Center 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 1 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fatigue and sleep assessed with self-report measures and actigraphy. (time frame: Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session.). 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 1 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.