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Effects of Meditation on Cognitive Function and Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162329
Recruitment Status : Active, not recruiting
First Posted : June 12, 2014
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Questionnaires Procedure: Electroencephalography (EEG) Procedure: Magnetic Resonance Imaging (fMRI Behavioral: Meditation Classes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Meditation on Cognitive Function and Quality of Life
Actual Study Start Date : October 22, 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy Control Group
Healthy 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. Electroencephalography (EEG) and magnetic resonance imaging (fMRI) scan performed. These should take a total of about 90 minutes to complete.
Behavioral: Questionnaires

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.

Other Name: Surveys

Procedure: Electroencephalography (EEG)

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.

Other Name: EEG

Procedure: Magnetic Resonance Imaging (fMRI

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.

Other Name: MRI

Experimental: Tibetan Meditation Group
Participants fill out several questionnaires at baseline, at completion of meditation classes, and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Electroencephalography (EEG) performed at baseline, at completion of classes, and at follow up visit. Participants have magnetic resonance imaging (fMRI) scan of brain at baseline, at completion of meditation classes, and at follow up visit. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped.
Behavioral: Questionnaires

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.

Other Name: Surveys

Procedure: Electroencephalography (EEG)

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.

Other Name: EEG

Procedure: Magnetic Resonance Imaging (fMRI

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.

Other Name: MRI

Behavioral: Meditation Classes
Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped.

Wait-List Group

Participants fill out several questionnaires at baseline and at follow up visit. The forms should take about 30 minutes to complete. Participants complete computer tests to check memory and concentration taking about 20 minutes to complete. Tests, EEG, and fMRI should take a total of about 90 minutes to complete. Participants receive the standard of care for cancer patients.

After 8 week follow up visit, Wait-List Group offered meditation program.

Behavioral: Questionnaires

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.

Other Name: Surveys

Procedure: Electroencephalography (EEG)

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.

Other Name: EEG

Procedure: Magnetic Resonance Imaging (fMRI

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.

Other Name: MRI




Primary Outcome Measures :
  1. Changes in Cognitive Function [ Time Frame: Assessed at baseline and 8 weeks after treatment ]
    Primary analyses based on difference scores of continuous variables measured at baseline and 8 weeks later. T tests or Wilcoxon two-sample tests used, depending on the distribution of the data. Reliable change index (RCI) used for the cognitive tasks. RCI based on standard error of measurement for each assessment and takes into account baseline levels of performance for any participant. A chi-square test used to compare the proportions of participants that fall into each classification in the meditation and control groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162329


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Brazil
Hospital Israelita Albert Einstein (HIAE)
Sao Paulo, Brazil, 05652-900
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Lorenzo Cohen, PHD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02162329    
Other Study ID Numbers: 2012-0156
NCI-2015-00469 ( Registry Identifier: NCI CTRP )
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Cognitive function
Questionnaires
Surveys
Electroencephalography
EEG
Magnetic resonance imaging
fMRI
Tibetan meditation
Quality of life
QOL