The Vitality Project: A Randomized Control Trial Comparing Effects of Qigong and Exercise/Nutrition Training on Fatigue, Emotional Health, and Stress in Fatigued Female Cancer Survivors

Abstract

AbstractCancer-related fatigue (CRF) is a common and burdensome, often long term side effect of cancer and its treatment. Many non-pharmacological treatments have been investigated as possible CRF therapies, including exercise, nutrition, health/psycho-education, and mind-body therapies. However, studies directly comparing the efficacy of these treatments are lacking. To fill this gap, we conducted a parallel single blind randomized control trial with women with CRF to directly compare the effects of Qigong (a form of mind-body intervention) (n=11) to an intervention that combined strength and aerobic exercise, plant-based nutrition and health/psycho-education (n=13). This design was chosen to determine the comparative efficacy of two non-pharmacologic interventions, with different physical demand intensity, in reducing the primary outcome measure of self-reported fatigue (FACIT ‘Additional Concerns’ subscale). Both interventions showed a mean fatigue improvement of more than double the pre-established minimal clinically important difference of three (Qigong: 7.068 +/- 10.30, Exercise/Nutrition: 8.846 +/- 12.001). Mixed effects ANOVA analysis of group x time interactions revealed a significant main effect of time, such that both groups significantly improved fatigue from pre- to post treatment (F(1,22)=11.898, p=.002, generalized eta squared effect size=.116) There was no significant difference between fatigue improvement between groups (independent samples t-test: p=.70), suggesting a potential equivalence or non-inferiority of interventions, which we could not definitively establish due to our small sample size. This study provides evidence from a small sample that Qigong improves fatigue similarly to standard exercise-nutrition. Qigong additionally significantly improved secondary measures of mood, emotion regulation, and stress, while exercise/nutrition significantly improved secondary measures of sleep/fatigue. These findings provide preliminary evidence for divergent mechanisms of fatigue improvement across interventions, with Qigong providing a gentler and lower-intensity alternative to exercise/nutrition. This clinical trial was registered with clinicaltrials.gov.