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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditative Movement (MM) | Experimental | The Meditative Movement (Qigong/Tai Chi Easy) program will be 8 weeks in duration with sessions once a week. Each session is approximately one hour. The PI will lead the MM sessions. The PI and the CRC will maintain contact with the MM group during the 8 weeks by telephone or in person. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditative Movement | Behavioral | The Meditative Movement program is a blend of meditation and exercise based on Tai Chi and Qigong. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Cognitive Impairments (CogPCI) | 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. | 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) | 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. | 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. |
| Impact on Quality of Life (CogQOL) | 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. | 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. |
| Comments From Others (CogOth) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Derived Neurotropic Factor (BDNF) Gene Expression | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Biologically Female
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| Name | Affiliation | Role |
|---|---|---|
| Francisco V Munoz, Ph.D. | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert and Beverly Lewis Family Cancer Care Center | Pomona | California | 91767 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Meditative Movement (MM) Group | minimum 45 years of age; female patients diagnosed with breast cancer, stages 0-III; between six months and five years past primary treatment; ability to speak or understand English; and post-menopausal for at least one year. Exclusion criteria: Women who were unable to stand (e.g., wheelchair or walker bound); patients who were too weak or ill; patients on antibiotics; women working on night shift; and patients with anemia or uncontrolled diabetes. Pregnant women, mentally disabled persons, and prisoners were excluded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Meditative Movement (MM) | The Meditative Movement (Qigong/Tai Chi Easy) program will be 8 weeks in duration with sessions once a week. Each session is approximately one hour. The PI will lead the MM sessions. The PI and the CRC will maintain contact with the MM group during the 8 weeks by telephone or in person. Meditative Movement: The Meditative Movement program is a blend of meditation and exercise based on Tai Chi and Qigong. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perceived Cognitive Impairments (CogPCI) | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
|
14 weeks
In the context of this study, an adverse event is when a participant withdraws from the study due to physical or emotional discomfort. The PI or the Clinical Trials Coordinator (CRC) will report immediately any adverse events and monitoring results to the IRB coordinator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meditative Movement (MM) | minimum 45 years of age; female patients diagnosed with breast cancer, stages 0-III; between six months and five years past primary treatment; ability to speak or understand English; and post-menopausal for at least one year. Exclusion criteria: Women who were unable to stand (e.g., wheelchair or walker bound); patients who were too weak or ill; patients on antibiotics; women working on night shift; and patients with anemia or uncontrolled diabetes. Pregnant women, mentally disabled persons, and prisoners were excluded. |
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This study enrolled a small number of study participants, however, the results of this study parallel the results of larger studies conducted on the effects of meditation, exercise, and mind-body practices such as Yoga or Tai Chi/Qigong on the cognitive functioning, anxiety and quality of life factors for breast cancer survivors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Munoz | ASU/PVHMC | 909-753-8391 | fmunoz007@verizon.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2018 | Feb 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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This is a single-group nonrandomized pilot study on the effects of 8 weeks of MM program on changes in cognitive function, anxiety, sleep quality, depression, and selected gene expression factors.
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| Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing | 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. | 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. |
| Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward | 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. | 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. |
| Pittsburg Sleep Quality Index (PSQI) | 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. | 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. |
| Profile of Mood States Short Form (POMS-SF) - Anxiety | 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. | 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. |
| Profile of Mood States Short Form (POMS-SF) - Depression | 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. | 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. |
| Nuclear Factor Kappa B (NF-kB1) Gene Expression | 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. | 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. |
| Tumor Protein 53 (TP53) Gene Expression | 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. | 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. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| (FACT-COG)-Perceived Cog Impairment | Mean | Standard Deviation | units on a scale |
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| FACT-COG: Perceived Cognitive Abilities | Mean | Standard Deviation | units on a scale |
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| FACT-COG: Perceived Impairments on Quality of Life | Mean | Standard Deviation | units on a scale |
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| FACT-COG: Comments from Others | Mean | Standard Deviation | units on a scale |
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| Wechsler Adult Intelligence Scale (WAIS-III) 3rdEdition-letter/number Seq | Mean | Standard Deviation | units on a scale |
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| Wechsler Adult Intelligence Scale (WAIS-III) 3rdEdition -Digit Span Forward and Backward | Mean | Standard Deviation | units on a scale |
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| Pittsburgh Sleep Quality Index (PSQI) | Mean | Standard Deviation | units on a scale |
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| Profile of Mood States Short Form - Anxiety (POMS-SF) | Mean | Standard Deviation | units on a scale |
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| Profile of Mood States Short Form - Depression (POMS-SF) | Mean | Standard Deviation | units on a scale |
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| Brain derived neurotrophic factor (BDNF) | Mean | Standard Deviation | fold change |
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| Nuclear Factor kappa B (NF-kB1) | Mean | Standard Deviation | fold change |
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| Tumor Protein 53 (TP53) | Mean | Standard Deviation | fold change |
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| Primary | Perceived Cognitive Abilities (CogPCA) | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Primary | Impact on Quality of Life (CogQOL) | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Primary | Comments From Others (CogOth) | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Primary | Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Primary | Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Primary | Pittsburg Sleep Quality Index (PSQI) | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Primary | Profile of Mood States Short Form (POMS-SF) - Anxiety | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Primary | Profile of Mood States Short Form (POMS-SF) - Depression | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Secondary | Brain Derived Neurotropic Factor (BDNF) Gene Expression | 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. | Posted | Mean | Standard Deviation | fold change | 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. |
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| Secondary | Nuclear Factor Kappa B (NF-kB1) Gene Expression | 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. | Posted | Mean | Standard Deviation | fold change | 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. |
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| Secondary | Tumor Protein 53 (TP53) Gene Expression | 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. | Posted | Mean | Standard Deviation | fold change | 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. |
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