Clinical trial NCT04213872: Gene Expression, Meditative Movement, and Emotional Distress (GME)
Official title: Gene Expression, Meditative Movement, and Emotional Distress (GME): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: breast cancer survivors
gene expression
emotional distress
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2019-12-30
Enrollment: 27
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Cognitive Impairments (CogPCI)
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.
measure: Perceived Cognitive Abilities (CogPCA)
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.
measure: Impact on Quality of Life (CogQOL)
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.
measure: Comments From Others (CogOth)
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.
measure: Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing
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.
measure: Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward
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.
measure: Pittsburg Sleep Quality Index (PSQI)
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.
measure: Profile of Mood States Short Form (POMS-SF) - Anxiety
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.
measure: Profile of Mood States Short Form (POMS-SF) - Depression
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.
Secondary outcomes:
measure: Brain Derived Neurotropic Factor (BDNF) Gene Expression
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.
measure: Nuclear Factor Kappa B (NF-kB1) Gene Expression
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.
measure: Tumor Protein 53 (TP53) Gene Expression
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.
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Robert and Beverly Lewis Family Cancer Care Center
state: California
Study officials:
affiliation: Arizona State University
name: Francisco V Munoz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: