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

Arizona State University (ASU)

Status: Completed

Conditions: Cognitive Impairment

Treatments: Behavioral: Meditative Movement

Study type: Interventional

Funder types: Other

Identifiers

NCT04213872

GME Study (SITE00000289)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Meditative Movement (MM)

Experimental group

Description:

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.

Treatment:

Behavioral: Meditative Movement