Patients with breast cancer often report fatigue and other associated symptoms that persist for months, even years, after treatment ends. In a recent feasibility pilot study of Qigong/Tai Chi Easy (QG/TCE), breast cancer survivors experienced significantly greater improvements in fatigue and trends for improvement compared to a sham Qigong control for sleep quality, depression and cognitive function. To build upon the promise of this study, and to further test intervention components that may elucidate what aspects of the intervention have the most impact, we propose a three-group, randomized trial to test effects of a 12 week QG/TCE intervention on fatigue and other symptoms at the end of 12 weeks, and again at 36 weeks. We will randomize 246 women, 6 months to 5 years past treatment for Stage 0- III breast cancer, aged 45-75, post-menopausal into one of three study arms. Two comparison groups to the QG/TCE will be used: an educational support (ES) group control and an active exercise (sham Qigong, SQG) with movements that are similar to QG/TCE, but without the focus on the breath and meditative state. The aim of this study is to test whether QG/TCE is more efficacious than a) a non-meditation based SQG intervention and b) a no-exercise, education/social support (ES) intervention for improving fatigue and other symptoms -- sleep quality, anxiety, depression, and cognitive function--in women after treatment for breast cancer. Based on a small pilot project in progress and prior anecdotal reports, we will also explore whether QG/TCE improves symptoms of peripheral neuropathy among BCSs more than comparison interventions. Finally, we will examine a set of participants biomarkers, including salivary cortisol and a set of candidate pro-inflammatory cytokines, selected as having some evidence for responding to QG/TCE-like practices and for being associated with fatigue, to explore possible mechanisms of the intervention effects on outcomes.
|Effective start/end date||5/1/15 → 4/30/20|
- HHS-NIH: National Cancer Institute (NCI): $3,299,737.00