NCT02162329

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable breast-cancer

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

9 years

First QC Date

June 10, 2014

Last Update Submit

October 18, 2022

Conditions

Breast Cancer

Keywords

Breast CancerCognitive functionQuestionnairesSurveysElectroencephalographyEEGMagnetic resonance imagingfMRITibetan meditationQuality of lifeQOL

Outcome Measures

Primary Outcomes (1)

  • Changes in Cognitive Function

    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.

    Assessed at baseline and 8 weeks after treatment

Study Arms (3)

Healthy Control Group

OTHER

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: QuestionnairesProcedure: Electroencephalography (EEG)Procedure: Magnetic Resonance Imaging (fMRI

Tibetan Meditation Group

EXPERIMENTAL

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: QuestionnairesProcedure: Electroencephalography (EEG)Procedure: Magnetic Resonance Imaging (fMRIBehavioral: Meditation Classes

Wait-List Group

OTHER

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: QuestionnairesProcedure: Electroencephalography (EEG)Procedure: Magnetic Resonance Imaging (fMRI

Interventions

QuestionnairesBEHAVIORAL

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.

Also known as: Surveys
Healthy Control GroupTibetan Meditation GroupWait-List Group
Electroencephalography (EEG)PROCEDURE

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.

Also known as: EEG
Healthy Control GroupTibetan Meditation GroupWait-List Group
Magnetic Resonance Imaging (fMRIPROCEDURE

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.

Also known as: MRI
Healthy Control GroupTibetan Meditation GroupWait-List Group
Meditation ClassesBEHAVIORAL

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

Tibetan Meditation Group

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage I - III female breast cancer patients who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment
  • Report cognitive impairment since starting chemotherapy as assessed by four questions from the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
  • to 65 years old
  • Able to read, write and speak English, Spanish, or Portuguese
  • Willing to come to MD Anderson Cancer Center (MDACC) or Hospital Israelita Albert Einstein (HIAE) for the meditation sessions and assessment sessions
  • Right handed (qEEG database comparison is specific to handedness. By requiring all participants be right handed, we will be consistent across EEG analysis.)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Women with no history of cancer)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: No history of prior chemotherapy)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: 35 to 65 years old)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Able to read, write, and speak English, Spanish, or Portuguese)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Willing to come to MDACC and HIAE for the assessment session)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Right handed)

You may not qualify if:

  • Diagnosis of a formal thought disorder (e.g., schizophrenia)
  • Any past neurologic insult that is known to affect brain function such as traumatic brain injury, dementia, encephalopathy, etc.
  • Mini-Mental State Examination score of 23 or below
  • Recurrent cancer
  • History of a neurological or psychological disorder that may interfere with the patient's ability to cooperate with study procedures
  • Factors contraindicated to fMRI
  • 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
  • Regularly practiced meditation (greater than once per week) in the year prior to study enrollment
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Diagnosis of a formal thought disorder (e.g. schizophrenia))
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of 23 or below)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Undergoing chemotherapy)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Mini-Mental State Examination score of 23 or below)
  • (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)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Primary caretaker of a cancer patient)
  • (PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Patients who have regularly practiced meditation (greater than once per week) in the year prior to study enrollment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hospital Israelita Albert Einstein (HIAE)

São Paulo, 05652-900, Brazil

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and QuestionnairesMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Lorenzo Cohen, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

October 22, 2013

Primary Completion

October 18, 2022

Study Completion

October 18, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(1)BR(1)