Trial Outcomes & Findings for Gene Expression, Meditative Movement, and Emotional Distress (GME) (NCT NCT04213872)

Last Updated: 2025-01-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

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.

Results posted on

2025-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	27
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meditative Movement (MM) n=14 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
(FACT-COG)-Perceived Cog Impairment	25.4 units on a scale STANDARD_DEVIATION 14.2 • n=5 Participants
FACT-COG: Perceived Cognitive Abilities	16.0 units on a scale STANDARD_DEVIATION 5.1 • n=5 Participants
FACT-COG: Perceived Impairments on Quality of Life	3.7 units on a scale STANDARD_DEVIATION 3.8 • n=5 Participants
FACT-COG: Comments from Others	1.5 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants
Wechsler Adult Intelligence Scale (WAIS-III) 3rdEdition-letter/number Seq	10.7 units on a scale STANDARD_DEVIATION 3.2 • n=5 Participants
Wechsler Adult Intelligence Scale (WAIS-III) 3rdEdition -Digit Span Forward and Backward	19.2 units on a scale STANDARD_DEVIATION 4.8 • n=5 Participants
Pittsburgh Sleep Quality Index (PSQI)	1.5 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Profile of Mood States Short Form - Anxiety (POMS-SF)	9.2 units on a scale STANDARD_DEVIATION 7.7 • n=5 Participants
Profile of Mood States Short Form - Depression (POMS-SF)	4.1 units on a scale STANDARD_DEVIATION 4.9 • n=5 Participants
Brain derived neurotrophic factor (BDNF)	0.11 fold change STANDARD_DEVIATION 0.9 • n=5 Participants
Nuclear Factor kappa B (NF-kB1)	171.7 fold change STANDARD_DEVIATION 25.4 • n=5 Participants
Tumor Protein 53 (TP53)	12.3 fold change STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Perceived Cognitive Impairments (CogPCI)	17.3 units on a scale Standard Deviation 10.5

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Perceived Cognitive Abilities (CogPCA)	19.2 units on a scale Standard Deviation 5.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Impact on Quality of Life (CogQOL)	1.8 units on a scale Standard Deviation 2.2

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Comments From Others (CogOth)	0.2 units on a scale Standard Deviation 0.4

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing	12.7 units on a scale Standard Deviation 2.8

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward	19.7 units on a scale Standard Deviation 4.4

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Pittsburg Sleep Quality Index (PSQI)	0.9 units on a scale Standard Deviation 0.7

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Profile of Mood States Short Form (POMS-SF) - Anxiety	4.2 units on a scale Standard Deviation 3.7

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Profile of Mood States Short Form (POMS-SF) - Depression	2.0 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Brain Derived Neurotropic Factor (BDNF) Gene Expression	0.30 fold change Standard Deviation 0.7

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Nuclear Factor Kappa B (NF-kB1) Gene Expression	173.7 fold change Standard Deviation 21.6

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Meditative Movement (MM) Group n=14 Participants 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.
Tumor Protein 53 (TP53) Gene Expression	13.1 fold change Standard Deviation 5.5

Adverse Events

Meditative Movement (MM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Francisco Munoz

ASU/PVHMC

Phone: 909-753-8391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place