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

Sponsor

Arizona State University (Other)

Overall Status

Completed

CT.gov ID

NCT02690116

Collaborator

University of Arizona (Other), Mayo Clinic (Other)

232

Enrollment

Location

Arms

58.9

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue	Other: Qigong/Tai Chi Easy Other: Sham Qigong Other: Educational Support	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

232 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Qigong/Tai Chi Easy The Qigong/Tai Chi Easy (QG/TCE) intervention has been standardized, manualized, and has a formal training program for instructors from the Institute of Integral Qigong and Tai Chi (IIQTC).	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 Comparator: Sham Qigong This active control group uses a gentle movement intervention, with similar types of movements with the same energy expenditure, but without the meditative states and breath focus as QG/TCE (validated in the pilot study using the Meditative Movement Inventory).	Other: 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.
Active Comparator: Educational Support The Recovery Support Group will consist of a classroom-style intervention, designed to educate, engage interaction, and maintain participation and attention over 8 weeks. This group will include readings/discussions specific to breast cancer, and social interaction facilitation.	Other: 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.

Arm

Intervention/Treatment

Experimental: Qigong/Tai Chi Easy

The Qigong/Tai Chi Easy (QG/TCE) intervention has been standardized, manualized, and has a formal training program for instructors from the Institute of Integral Qigong and Tai Chi (IIQTC).

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 Comparator: Sham Qigong

This active control group uses a gentle movement intervention, with similar types of movements with the same energy expenditure, but without the meditative states and breath focus as QG/TCE (validated in the pilot study using the Meditative Movement Inventory).

Other: Sham Qigong

Active Comparator: Educational Support

The Recovery Support Group will consist of a classroom-style intervention, designed to educate, engage interaction, and maintain participation and attention over 8 weeks. This group will include readings/discussions specific to breast cancer, and social interaction facilitation.

Other: 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.

Outcome Measures

Primary Outcome Measures

Fatigue Symptom Inventory [Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months.]
Fatigue

Secondary Outcome Measures

Profile of Mood States Short Form (POMS-SF) [Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months.]
Anxiety and depression
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) [Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months.]
Cognitive function
Pittsburgh Sleep Quality Index (PSQI) [Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months]
Sleep quality
Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ) [Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months]
Physical activity
Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits [Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks]
Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ)
Diurnal salivary samples (enzyme assay) [Change from baseline salivary cortisol to salivary cortisol at 8 weeks]
Salivary cortisol
ActiGraph GT3X activity monitor [Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months]
Objective measurement of physical activity
ActiGraph GT3X activity monitor [Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months]
Objective measurement of sleep quality

Other Outcome Measures

Functional Assessment of Cancer Therapy-Cognitive Function Neuropathy (FACT-COGNtx) [Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months]
Peripheral Neuropathy

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)