N/A N=27 Supportive Care

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

Cognitive Impairment

Bottom Line

View on ClinicalTrials.gov: NCT04213872 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Perceived Cognitive Impairments (CogPCI) — 17.3 units on a scale — p=.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Meditative Movement (Behavioral)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Arizona State University
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Perceived Cognitive Impairments (CogPCI)	17.3	.01 sig
PRIMARY Perceived Cognitive Abilities (CogPCA)	19.2	.03 sig
PRIMARY Impact on Quality of Life (CogQOL)	1.8	.04 sig
PRIMARY Comments From Others (CogOth)	0.2	.04 sig
PRIMARY Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Letter-Number Sequencing	12.7	.01 sig
PRIMARY Wechsler Adult Intelligence Scale-Third Edition (WAIS-III): Digit Span Forward and Backward	19.7	.60
PRIMARY Pittsburg Sleep Quality Index (PSQI)	0.9	.03 sig
PRIMARY Profile of Mood States Short Form (POMS-SF) - Anxiety	4.2	.05
PRIMARY Profile of Mood States Short Form (POMS-SF) - Depression	2.0	.08
SECONDARY Brain Derived Neurotropic Factor (BDNF) Gene Expression	0.30	.30
SECONDARY Nuclear Factor Kappa B (NF-kB1) Gene Expression	173.7	.80
SECONDARY Tumor Protein 53 (TP53) Gene Expression	13.1	.61

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04213872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.