Effects of Meditation on Cognitive Function and Quality of Life
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The goal of this research study is to test Tibetan meditation as a therapy to teach cancer
      patients to change their brain functioning and to improve quality of life. Researchers want
      to compare the cancer patients' outcomes to people who have never had cancer.
    

Detailed description: 
      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.
    

Intervention name(s): Questionnaires; Electroencephalography (EEG); Magnetic Resonance Imaging (fMRI; Meditation Classes
Intervention type(s): Behavioral; Procedure; Procedure; Behavioral
Intervention description(s): Participants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete.
Meditation Group and Wait-List Group also complete questionnaires at follow up visit.; Meditation Group and Wait-List Group: Electroencephalography (EEG) performed at baseline and at follow up visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions.
Healthy Control Group: Electroencephalography (EEG) performed at study visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions.; Healthy Control Group: Magnetic resonance imaging (fMRI) scan performed.
Meditation Group and Wait-List Group: Magnetic resonance imaging (fMRI) scan of brain performed at baseline and at follow up visit.; Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped.
Other intervention name(s): Surveys; EEG; MRI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Cognitive function; Questionnaires; Surveys; Electroencephalography; EEG; Magnetic resonance imaging; fMRI; Tibetan meditation; Quality of life; QOL