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



Status:Recruiting
Conditions:Breast Cancer, Other Indications
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:45 - 75
Updated:3/21/2019
Start Date:February 1, 2016
End Date:March 3, 2020
Contact:Linda Larkey, PhD
Email:Linda.Larkey@asu.edu
Phone:(602)496-0740

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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.

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.

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)
We found this trial at
1
site
Phoenix, Arizona 85004
Phone: 602-496-0740
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Phoenix, AZ
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