Clinical trial · Interventional
Effects of Meditation on Cognitive Function and Quality of Life
NCT02162329CI-TRIAL-00061567completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electroencephalography (EEG) | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging (fMRI | Procedure | — | UNRESOLVED |
| Meditation Classes | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Healthy Control Group
- description
- 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.
- interventionNames
- Behavioral: Questionnaires
- Procedure: Electroencephalography (EEG)
- Procedure: Magnetic Resonance Imaging (fMRI
- type
- EXPERIMENTAL
- label
- Tibetan Meditation Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.