Effects of Meditation on Cognitive Function and Quality of Life

Tibetan Meditation Program:

During the meditation program, you will learn several concepts such as focus, visualization,
and sound. You will have up to 16 classes for 8 weeks. They should take about 60 minutes
each.

First Study Visit:

If you choose to take part in this study, you will be asked to fill out several
questionnaires. You will be asked questions about your memory and concentration, mood,
fatigue, how you have been feeling, and your general quality of life. The forms should take
about 30 minutes to complete.

You will complete some computer tests 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. These
tests should take about 20 minutes to complete.

You will then have an electroencephalography (EEG) done. An EEG checks a person's brainwaves.
During the EEG, a snug cap which contains small electrodes will be placed on your head to
measure the electrical patterns coming from the brain. This is like the way a doctor listens
to your heart from the surface of your skin. During recording of the EEG, you will be asked
to complete 3 tests to check your attention, short-term memory, and levels of emotions. For
example, for one test you will use a use a keypad to choose a word's name that is a color
(such as if the word "blue" written in the color red, the correct answer would be red).The
EEG and tests will take about 45 minutes to one hour.

You will also have a functional magnetic resonance imaging (fMRI) scan of your brain. During
the scan, you will lie down on your back with both arms extended by your sides. You will be
fitted with earplugs and/or headphones to help dampen the noise caused by the scanner. The
lights will also be dimmed. You will then lie still until the scan is over. The scan will
take about 20 minutes.

The tests, EEG, and fMRI should take a total of about 90 minutes to complete.

Blood (about 1 tablespoon) will be drawn for tests to measure hormones and your immune system
responses. This should take about 15 minutes.

All assessments will be performed at baseline and after the completion of classes.

Study Groups:

After the first study visit, you will be randomly assigned to 1 of 2 study groups. You will
have about a 1 out of 2 chance of being assigned to each group. The groups are randomly
assigned, but it is also based on other factors such as your age and the status of the
disease.

Participants in the first group will take part in a meditation program. You will take part in
up to 16 meditation classes for a total of 8 weeks. The meditation sessions may take place on
any 2 days of the week at MD 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. A trained meditation instructor will teach the meditation sessions.
Participants will be asked to continue daily meditation practice at home outside of the
classes and will be given a CD to guide home practice. All sessions will be videotaped. This
is so the researchers can keep track of the quality of the sessions. The audio and video
files are digital and will be deleted after all the data are studied.

Participants in the second group will be in a wait-list group. You will continue to receive
the standard of care for cancer patients, but you will not take part in the meditation
program. You will be given the opportunity to take part in the meditation program and similar
measures will be collected from you at similar times as that described below.

All participants must agree not to take part in any other meditation programs for as long as
you take part in this study.

Follow-up Study Visit:

Within a week after the last meditation session (8 weeks after baseline), all participants
will be asked to fill out a packet of questionnaires (like the ones at the first visit). It
should take about 50 minutes to complete all of the questionnaires. You will have some tests
to check your memory and concentration, similar to the tests you took at your initial visit.
You will have another EEG and fMRI. You will have blood drawn.

After the 8 week follow-up, if you were in the meditation group your participation on this
study will be over. If you were in the wait-list group you will be offered the meditation
program and you will complete the same questionnaires as before. You will not have any more
EEG or fMRI measurements or blood drawn.

You may receive reminder calls for each session and the follow-up study visit.

Length of Study:

If you are in the treatment group, you will be on study for up to 8 weeks. If you are in the
waitlist group and decide to take meditation classes after the first 8 weeks, you may be on
study for up to 16 weeks.

This is an investigational study.

Up to 140 participants will take part in this study. Up to 10 pilot participants without
cancer will be take part in this study. Up to 40 participants without cancer and up to 80
patients will be enrolled. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Stage I - III female breast cancer patients who have undergone chemotherapy (either
neoadjuvant or adjuvant) 6 - 60 months prior to recruitment

2. Report cognitive impairment since starting chemotherapy as assessed by four questions
from the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)

3. 35 to 65 years old

4. Able to read, write and speak English, Spanish, or Portuguese

5. Willing to come to MD Anderson Cancer Center (MDACC) or Hospital Israelita Albert
Einstein (HIAE) for the meditation sessions and assessment sessions

6. Right handed (qEEG database comparison is specific to handedness. By requiring all
participants be right handed, we will be consistent across EEG analysis.)

7. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Women with no history of cancer)

8. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: No history of prior chemotherapy)

9. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: 35 to 65 years old)

10. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Able to read, write, and speak English,
Spanish, or Portuguese)

11. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Willing to come to MDACC and HIAE for
the assessment session)

12. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Right handed)

Exclusion Criteria:

1. Diagnosis of a formal thought disorder (e.g., schizophrenia)

2. Any past neurologic insult that is known to affect brain function such as traumatic
brain injury, dementia, encephalopathy, etc.

3. Mini-Mental State Examination score of 23 or below

4. Recurrent cancer

5. History of a neurological or psychological disorder that may interfere with the
patient's ability to cooperate with study procedures

6. Factors contraindicated to fMRI

7. Any extreme mobility issues (e.g. unable to get in or out of a chair unassisted,
extremity issues such as neuropathy that limits physical manipulation of objects

8. Regularly practiced meditation (greater than once per week) in the year prior to study
enrollment

9. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Diagnosis of a formal thought disorder
(e.g. schizophrenia))

10. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of
23 or below)

11. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Undergoing chemotherapy)

12. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of
23 or below)

13. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Any extreme mobility issues (e.g.
unable to get in or out of a chair unassisted, extremity issues such as neuropathy
that limits physical manipulation of objects)

14. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Primary caretaker of a cancer patient)

15. (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Patients who have regularly practiced
meditation (greater than once per week) in the year prior to study enrollment)