Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors

Fatigue Clinical Trial

Official title:

Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690116
• Other study ID #: 1R01CA182901-01A1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2021
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether Meditative Movement (based on a standardized and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other symptoms in women after treatment for breast cancer than (a) a non-meditative "sham" Qigong active intervention and (b) an inactive education / support group.

Description:

Patients with breast cancer often report fatigue and other associated symptoms that persist for months, even years, after treatment ends. In a recent pilot study of Qigong/Tai Chi Easy (QG/TCE, a low-intensity form of Meditative Movement), fatigued breast cancer survivors experienced greater improvements in fatigue (medium effect size, .56); compared to a "sham" Qigong control intervention (also low-intensity activity). Trends for improvement compared to control were found for sleep quality and depression. Recruitment for the single-site implementation was steady, and feasible. To build upon the promise of this pilot study, and to further test intervention components that may elucidate what aspects of the intervention have the most impact, a three-group, randomized trial will be undertaken to test effects of an 8-week QG/TCE intervention on fatigue and other symptoms at the end of 8 weeks, and 24 weeks post-intervention. 246 (attrition to 210) women who are 6 months to 10 years past treatment for Stage 0- III breast cancer, aged 45-75, and post-menopausal, will be randomized into one of three study arms. Two comparison groups will be used, an educational support (ES) group control and an active sham Qigong (SQG) group with movements that are similar to and with the same level of physical activity intensity as QG/TCE, but without the focus on the breath and meditative state. These treatments allow for separation of effects associated with gentle exercise alone (controlled in SQG) and education/social support alone without any exercise (controlled in ES) relative to the mind-body practice of QG/TCE, to distinguish unique effects of the meditative and breath foci. The study will be implemented in two sites in a large, metropolitan area, including one low-income hospital (and catchment neighborhood) with larger numbers of Latina survivors where our research team has extensive community connections and cultural experience implementing exercise and meditative movement programs. Psychometrics and biomarkers related to symptoms before and after the interventions will be examined to further our understanding of the mechanisms associated with effects of QG/TCE, as distinct from ES and SQG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosed with breast cancer, stage 0-III
• Between 6 months and 10 years past primary treatment
• Post-menopausal
• Experiencing fatigue (scoring < 75 on "Vitality" scale of Short Form (SF)-36)
• English-speaking or Spanish-speaking

Exclusion Criteria:

• Women who are unable to stand for 10-minute segments
• Women who have had substantial experience with mind-body practices that blend movement with mindfulness/breathing techniques, such as Yoga, Tai Chi, or Qigong
• Women who work night shifts (fatigue-related factor)
• Restless leg syndrome (fatigue-related factor)
• Hypothyroidism (fatigue-related factor)
• Currently diagnosed with anemia (fatigue-related factor)
• Uncontrolled diabetes (fatigue-related factor)
• Major severe clinical depression (fatigue-related factor)
• Use of antihistamine, cyclosporins, corticosteroids, sleeping aids
• Regular use of alcohol (more than 2 drinks per day)

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• Qigong/Tai Chi Easy
Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
• Sham Qigong
Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
• Educational Support
Class times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Mayo Clinic, University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Assessment of Cancer Therapy-Cognitive Function Neuropathy (FACT-COGNtx)	Peripheral Neuropathy	Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months
Primary	Fatigue Symptom Inventory	Fatigue	Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.
Secondary	Profile of Mood States Short Form (POMS-SF)	Anxiety and depression	Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.
Secondary	Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG)	Cognitive function	Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Sleep quality	Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months
Secondary	Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ)	Physical activity	Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months
Secondary	Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits	Inflammatory biomarkers (IL-1ß, IL-6,TNF-a; IFN-?)	Change from baseline Inflammatory biomarkers (IL-1ß, IL-6,TNF-a; IFN-?) to Inflammatory biomarkers at 8 weeks
Secondary	Diurnal salivary samples (enzyme assay)	Salivary cortisol	Change from baseline salivary cortisol to salivary cortisol at 8 weeks
Secondary	ActiGraph GT3X activity monitor	Objective measurement of physical activity	Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months
Secondary	ActiGraph GT3X activity monitor	Objective measurement of sleep quality	Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months