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

NCT04213872 | Completed Results DMC

• 1 other identifier: GME Study (SITE00000289)
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment

Keywords

breast cancer survivors; gene expression; emotional distress

Outcome Measures

Primary Outcomes (9)

• 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.

• 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.

Secondary Outcomes (3)

• Brain Derived Neurotropic Factor (BDNF) Gene Expression

  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.

• Nuclear Factor Kappa B (NF-kB1) Gene Expression

  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

  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.

Study Arms (1)

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.

Behavioral: Meditative Movement

Interventions

Meditative Movement BEHAVIORAL

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

Meditative Movement (MM)

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Biologically Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (1)

Robert and Beverly Lewis Family Cancer Care Center

Pomona, California, 91767, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Francisco Munoz
• Organization: ASU/PVHMC

fmunoz007@verizon.net

909-753-8391

Study Officials

• Francisco V Munoz, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: December 30, 2019
• Study Start: July 17, 2017
• Primary Completion: November 15, 2018
• Study Completion: September 15, 2020
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)