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

NCT ID: NCT04213872

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-17
• Study Completion Date: 2020-09-15

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.

Conditions

Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Meditative Movement

Intervention Type: BEHAVIORAL

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

Interventions

Meditative Movement

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco V Munoz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Robert and Beverly Lewis Family Cancer Care Center

Pomona, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GME Study (SITE00000289)

Identifier Type: -

Identifier Source: org_study_id