Breast CancerNCT00556218
Meditation and Cognitive Function in Women With Breast Cancer
A study testing Tibetan Meditation Program and No Meditation in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to learn if participating in a Tibetan meditation program helps to improve quality of life for women after chemotherapy and during recovery from breast cancer. Whether the meditation program helps to improve brain function and sleep quality will also be studied. 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?
- Tibetan Meditation Program and No Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2007to 10 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 I - III breast cancer who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment.
- Women who report cognitive impairment since starting chemotherapy as assessed by four questions from the FACT-Cog.
- Women must be 18 years or older.
- Women must be able to read, write and speak English.
- Women must be currently undergoing hormone therapy (e.g., Tamoxifen or AIs)
- Willing to come to MDACC for the meditation sessions and assessment sessions.
- Women must be within 2 hours driving distance of MDACC.
Who cannot join
- Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- Women with metastatic disease to the brain or any past neurologic injury.
- Women with a Mini-Mental State Examination score of 23 or below.
- Women with recurrent cancer
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: Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women With Breast Cancer
The goal of this behavioral research study is to learn if participating in a Tibetan meditation program helps to improve quality of life for women after chemotherapy and during recovery from breast cancer. Whether the meditation program helps to improve brain function and sleep quality will also be studied.
Read the detailed description
Screening Tests:
During the "screening" visit, you will be asked 4 questions about your memory and concentration abilities. Based on how you score on this screening questionnaire, you may not be eligible to participate in the study even if you have already signed the informed consent form.
If you are found to be eligible for the study based on the screening questionnaire, you will complete some tests during the screening visit to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. You will also complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the tests and questionnaires should take about 90 minutes to complete.
Study Groups:
You will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. People in Group 1 will take part in a Tibetan meditation program. People in Group 2 will be placed on a waiting list. They may participate in the meditation program 3 months after being enrolled in the study (when Group 1 has finished the follow-up visit).
Meditation Sessions:
If you are Group 1, you have 12 sessions of Tibetan meditation (2 times a week), over a 6-week period. You will be asked to complete a form asking about your satisfaction with the program at the start of each week. The form will take 1-2 minutes to complete.
The meditation sessions will take place at M. D. Anderson. During the meditation sessions, you will do deep breathing and visualization exercises and produce some sounds like "Ah." Each session will last about 60 minutes. One (1) or more of these meditation sessions may be videotaped by the study staff for check the quality of the sessions. Only the study staff will be able to view this videotape. All videos will be destroyed after the data is collected.
Participants in both groups will be mailed a questionnaire packet to fill out and send back (return postage will be included in the packets) at 1 month and then at the end of the meditation sessions (2 months). The questionnaires will ask about your mood, quality of life, and other things like sleeping habits and nervousness. The packet will take about 45 minutes to fill out. If you are in Group 2, you will receive packets at about the same time.
Your responses on these questionnaires will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked in these questionnaires (for example, if you feel depressed or distressed), please contact your doctor.
Follow-up Visit:
One (1) month after the last meditation session (or at a similar time, for participants in Group 2), you will be asked to return to the clinic. You will take some tests to check your memory and concentration, similar to the tests you took at your screening visit. You will complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the questionnaires and tests should take about 90 minutes to complete.
Once the follow-up visit is complete, the study is over. After Group 1 has completed the follow-up visit, Group 2 will be given the option to take the meditation classes.
This is an investigational study. Up to 60 participants will be enrolled in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Tibetan Meditation Program, No Meditation
- Keywords
- Breast Cancer, Tibetan Meditation, Quality of Life, Cognitive Function, QOL
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibetan Meditation ProgramBehavioural
12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes.
No MeditationBehavioural
No meditation; usual care.
| Study group | Role | What they receive |
|---|---|---|
| Tibetan Meditation | Other | Not described Receives: Behavioral: Tibetan Meditation Program |
| No Meditation | Other | Not described Receives: Behavioral: No Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)
Measured: 2 Years
Women's Reported Satisfaction with Tibetan Meditation intervention
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study start24 Oct 2007
- Primary completion10 Aug 2022
- Study completion10 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556218
- Sponsor's protocol ID
- 2007-0311
- Status last verified
- Aug 2022
- First submitted
- 7 Nov 2007
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00556218
- Acronym / sponsor ID
- 2007-0311
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Tibetan Meditation, Quality of Life, Cognitive Function, QOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Oct 2007 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 9 Nov 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.
The goal of this behavioral research study is to learn if participating in a Tibetan meditation program helps to improve quality of life for women after chemotherapy and during recovery from breast cancer. Whether the meditation program helps to improve brain function and sleep quality will also be studied.
Detailed description
Screening Tests:
During the "screening" visit, you will be asked 4 questions about your memory and concentration abilities. Based on how you score on this screening questionnaire, you may not be eligible to participate in the study even if you have already signed the informed consent form.
If you are found to be eligible for the study based on the screening questionnaire, you will complete some tests during the screening visit to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. You will also complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the tests and questionnaires should take about 90 minutes to complete.
Study Groups:
You will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. People in Group 1 will take part in a Tibetan meditation program. People in Group 2 will be placed on a waiting list. They may participate in the meditation program 3 months after being enrolled in the study (when Group 1 has finished the follow-up visit).
Meditation Sessions:
If you are Group 1, you have 12 sessions of Tibetan meditation (2 times a week), over a 6-week period. You will be asked to complete a form asking about your satisfaction with the program at the start of each week. The form will take 1-2 minutes to complete.
The meditation sessions will take place at M. D. Anderson. During the meditation sessions, you will do deep breathing and visualization exercises and produce some sounds like "Ah." Each session will last about 60 minutes. One (1) or more of these meditation sessions may be videotaped by the study staff for check the quality of the sessions. Only the study staff will be able to view this videotape. All videos will be destroyed after the data is collected.
Participants in both groups will be mailed a questionnaire packet to fill out and send back (return postage will be included in the packets) at 1 month and then at the end of the meditation sessions (2 months). The questionnaires will ask about your mood, quality of life, and other things like sleeping habits and nervousness. The packet will take about 45 minutes to fill out. If you are in Group 2, you will receive packets at about the same time.
Your responses on these questionnaires will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked in these questionnaires (for example, if you feel depressed or distressed), please contact your doctor.
Follow-up Visit:
One (1) month after the last meditation session (or at a similar time, for participants in Group 2), you will be asked to return to the clinic. You will take some tests to check your memory and concentration, similar to the tests you took at your screening visit. You will complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the questionnaires and tests should take about 90 minutes to complete.
Once the follow-up visit is complete, the study is over. After Group 1 has completed the follow-up visit, Group 2 will be given the option to take the meditation classes.
This is an investigational study. Up to 60 participants will be enrolled 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibetan Meditation | Other | Behavioral: Tibetan Meditation Program |
| No Meditation | Other | Behavioral: No Meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women with stage I - III breast cancer who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment.
- Women who report cognitive impairment since starting chemotherapy as assessed by four questions from the FACT-Cog.
- Women must be 18 years or older.
- Women must be able to read, write and speak English.
- Women must be currently undergoing hormone therapy (e.g., Tamoxifen or AIs)
Key exclusion criteria (4 listed)
- Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- Women with metastatic disease to the brain or any past neurologic injury.
- Women with a Mini-Mental State Examination score of 23 or below.
- Women with recurrent cancer
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 |
|---|---|---|
| Tibetan Meditation Program12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes. | Behavioural | Tibetan Meditation |
| No MeditationNo meditation; usual care. | Behavioural | No Meditation |
Primary outcome
Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)
Time frame: 2 Years
Women's Reported Satisfaction with Tibetan Meditation intervention
Time frame: 2 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 30 Aug 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 Tibetan Meditation Program and No Meditation 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 7 inclusion and 4 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 30 Aug 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?
Number of Eligible Women Approached Who Consented to be in Trial (Feasibility) (time frame: 2 Years). The study lists 2 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 30 Aug 2022.