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NCT Number: NCT04213872

Gene Expression, Meditative Movement, and Emotional Distress (GME)

Study Title: Gene Expression, Meditative Movement and Emotional Distress (GME)

Background and Objectives:

Breast cancer survivors (BCS) often report decrements in cognitive functioning. Cognitive impairment (CI) is generally understood as resulting from chemotherapy or radiation, but may also result from chronic emotional distress experienced by breast cancer patients and survivors. Meditation and exercise are both known to reduce stress, with growing evidence for the potential of each to also improve cognitive functioning in cancer patients and survivors. A Meditative Movement (MM) program (Qigong/Tai Chi Easy) offers the potential of combining both benefits of meditation and exercise for breast cancer survivors. This is a pilot study, testing the MM program to effect changes in cognitive functioning and associated symptoms/conditions such as anxiety, depression, sleep quality and using gene expression factors as biomarkers to potentially measure the molecular signature of these changes. Forty BCS will be consented and assigned to an intensive eight week MM program. Cognitive functioning and associated symptoms/conditions will be assessed before and after the 8-week MM program to examine the participants' behaviors and symptoms. Peripheral blood samples will be collected before and after the 8-week MM program and will be analyzed for gene expression changes. If successful, this study may provide preliminary data for a full powered randomized control trial if results show promise in the psycho-behavioral outcomes and genomic expression results.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Robert and Beverly Lewis Family Cancer Care Center

Pomona, California, 91767, United States

About this study

This is a single-group pilot study on the effects of 8 weeks of MM practice on changes in cognitive function, anxiety, sleep quality, depression, and selected gene expression factors. Forty BCS will be consented and assigned to an intensive eight-week MM program. The forty BCS will be nonrandomly assigned to the eight-week MM program with no control group. The forty BCS will be organized in cohorts of 10 for the 8-week MM program. Cognitive functioning and associated symptoms/conditions data will be collected before and after the 8-week MM program to assess cognitive functioning, anxiety, depression, and sleep-quality. This data will be analyzed using the IBM SPSS Statistics program. Peripheral blood samples will be collected before and after the 8-week MM program. The gene expression data will be processed and analyzed by the bioinformatics team at the Single-Cell, Sequencing, and CyTOF Core (SC2), Children's Hospital Los Angeles (CHLA), Los Angeles.

Endpoints:

Endpoint 1: The Meditative Movement (MM) program will affect cognitive impairment.

Endpoint 2: The Meditative Movement (MM) program will affect anxiety, depression, and sleep quality.

Endpoint 3: The MM program will affect gene expression associated with cognitive impairment and associated symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients diagnosed with breast cancer, Stage 0- III
  • Between 6 months and 5 years past primary treatment
  • 45 years of age and older
  • Post-menopausal
  • Speak or understand English

Exclusion criteria

  • Women who are unable to stand (e.g., wheelchair or walker bound)
  • Patients who are too weak or ill
  • Women on antibiotics.
  • Working night shift
  • Anemia
  • Uncontrolled diabetes

Treatment and study plan

Meditative Movement

Behavioral

The Meditative Movement program is a blend of meditation and exercise based on Tai Chi and Qigong.

Primary outcomes

  1. Perceived Cognitive Impairments (CogPCI)

    Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    Perceived Cognitive Impairments (CogPCI) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 20 items. The range of values are 0-80 with lower scores signifying better outcomes.

  2. Perceived Cognitive Abilities (CogPCA)

    Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    Perceived Cognitive Abilities (CogPCA) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 9 items. The range of values are 0-36 with higher scores signifying better outcomes.

  3. Impact on Quality of Life (CogQOL)

    Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    Impact on Quality of Life (CogQOL) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 4 items. The range of values are 0-16 with lower scores signifying better outcomes.

  4. Comments From Others (CogOth)

    Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    Comments from Others (CogOth) is a patient self-report and validated subscale of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG), 4 items. The range of values are 0-16 with lower scores signifying better outcomes.

  5. Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing

    Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    WAIS-III: Letter-Number Sequencing measures working memory using letters and numbers in sequence recall. The scoring range is 0 to 21 with higher scores meaning better outcomes.

  6. Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward

    Time frame: Measures data on cognitive functioning were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    WAIS-III): Digit Span Forward and Backward measures working memory using numbers in a series recall. The scoring range is 0 to 30 with higher scores meaning better outcomes.

  7. Pittsburg Sleep Quality Index (PSQI)

    Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    The PSQI is a 19-item self-report questionnaire designed to assess sleep quality and disturbances over a I-month interval. The Pittsburgh Sleep Quality Index (PSQI): 19 items assess sleep, including subscales for subjective sleep quality, sleep latency, sleep duration, sleep disturbance, habitual sleep efficiency, daytime dysfunction and use of sleep medications. A global PSQI score >5 distinguishes good from poor sleepers. Lower scores mean better outcomes.

  8. Profile of Mood States Short Form (POMS-SF) - Anxiety

    Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    The POMs-SF consists of 37 items, adjectives scored on a 5-point Likert scale. POMS consists of the Total Mood Disturbance (TMD) dimensions (tension-anxiety; depression-dejection; anger-hostility; confusion-bewilderment. This pilot study reported results for the tension-anxiety TMD dimensions (12 items). Lower scores mean better outcomes.

  9. Profile of Mood States Short Form (POMS-SF) - Depression

    Time frame: Measures data on associated symptoms/conditions were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    The POMs-SF consists of 37 items, adjectives scored on a 5-point Likert scale. POMS consists of the Total Mood Disturbance (TMD) dimensions (tension-anxiety; depression-dejection; anger-hostility; confusion-bewilderment. This pilot study reported results for the depression-dejection TMD dimension (12 items). Lower scores mean better outcomes.

Secondary outcomes

  1. Brain Derived Neurotropic Factor (BDNF) Gene Expression

    Time frame: Measures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    The BDNF gene regulates synaptic plasticity associated with cognitive functioning. Increased levels of BDNF gene expression are associated with improved cognitive functioning. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Higher scores mean better outcomes.

  2. Nuclear Factor Kappa B (NF-kB1) Gene Expression

    Time frame: Measures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    Decreased levels of NF-kB1 gene expression are associated with improvements in managing chronic stress. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Lower scores indicate better outcomes.

  3. Tumor Protein 53 (TP53) Gene Expression

    Time frame: Measures data on gene expression were collected one week before and one week after the 8-week MM program. Paired Sample t-test of SPSS were used to analyze data and report p-values within four weeks of final post-MM data collection.

    Increased TP53 gene expression is associated with suppressing cancer growth. Blood samples were collected post-intervention for RNA Sequencing to measure RNA levels as indicators of gene expression. Higher scores mean better outcomes.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Children's Hospital Los Angeles

Registry information

Official study title

Gene Expression, Meditative Movement, and Emotional Distress (GME): A Pilot Study

Acronym: GME

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Dec 30, 2019
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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