Randomized controlled trial testing Tai Chi Easy/Qigong and Sham Qigong on breast cancer survivors’ fatigue and associated symptoms.

In 2025, the United States (US) is expected to have approximately 316,950 new reported cases of breast cancer [1]. Increasing rates of breast cancer along with improvements in prognosis means that the number of breast cancer survivors (BCSs) is growing across all US populations, regardless of race, ethnicity, and socioeconomic status [2]. As of January 2022, it was estimated that there were over 18 million cancer survivors in the US with breast as the most common cancer site for women with 4,055,770 BCSs [3]. As the number of cancer survivors rises, attention has shifted to the effects of cancer-related treatment on psychological and physical symptoms during and after treatment that reduce quality of life [[4], [5], [6]].

Fatigue remains the most frequently reported symptom of patients undergoing treatment for breast cancer, and has been associated with the initial stress of diagnosis, as well as surgery, chemotherapy and radiation therapy across all stages [4,7,8]. Cancer-related fatigue has been defined as a distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatments that is not proportional to recent activity and interferes with usual functioning [9]. This set of fatigue experiences has been shown to endure well past the period of treatment for BCSs; persistent fatigue is known to profoundly reduce quality of life including social, psychological, functional and even financial well-being [3,4,6,[10], [11], [12]].

The etiology of cancer-related fatigue has been suggested to be a complex interaction of biopsychosocial responses beyond the disease and treatment factors [10,11,13]. Multifactor processes including predisposing risks (e.g., early childhood trauma and history of depression), as well as the development of stress responses such as sleep disorders, neuro-immune and inflammatory responses, and specific hormonal and metabolic changes, all feature centrally as candidates of the etiology of fatigue for those under treatment as well as into survivorship [[10], [11], [12], [13], [14]]. As such, pre-existing conditions as well as the stress-related biospsychosocial responses along the course of treatment are suggested as underlying factors in the symptom clusters noted in BCSs [12,13]. BCSs, in particular, experience persistent sleep disturbance that arises in the context of the stress of diagnosis, treatment, physical and psychiatric factors [15,16]. Sleep disturbance affects between 20 % and 70 % of newly diagnosed or recently treated breast cancer patients, with severe sleep disturbance considered to be one of the primary predictors of fatigue [15]. Furthermore, one-third of BCSs experience depression and anxiety [17] and 21–25 % report specific difficulties with cognitive function over the course of diagnosis, treatment and up to one year follow-up [18,19]. These reports of cognitive impairment collectively impact social factors, work, self-perception, and quality of life through years of survivorship [20].

Exploration of non-pharmacological options to address fatigue and other persistent symptoms, including mind-body practices such as meditative movement, is common, and continues to grow among cancer survivors [5,21]. Meditative movement is defined as those practices that utilize movement or posture, with a focus on the breath and a meditative state to achieve deep states of relaxation and includes (but not limited to) Yoga, Tai Chi, and Qigong [22]. Tai Chi and Qigong are popular mind-body interventions that have been shown to ameliorate a number of biopsychosocial factors (e.g., anxiety, sleep) [[23], [24], [25], [26], [27], [28], [29], [30], [31]], generally through the pathway of reducing stress responses.

Research and reviews of the benefits of meditative movement as an intervention for fatigued cancer survivors describe improvements in fatigue, sleep, depression, cognitive function and overall quality of life [10,12,[32], [33], [34], [35], [36]] and these benefits have also specifically been found for BCSs [5,[37], [38], [39]]. Notably, the factors most central to the etiology of fatigue (i.e., biopsychosocial responses to stress resulting in neuroinflammation and lack of sleep) are also known to improve with meditative movement [[34], [35], [36]], suggesting the importance of continued research for these interventions for BCSs.

The reviews and current studies testing meditative movement with fatigued cancer patients (with the median intervention period of 12 weeks) have been shown in meta-analyses to successfully reduce fatigue [35,36]. While the evidence for Tai Chi and Qigong to reduce cancer-related fatigue and related symptoms is growing, there is room for refinement of this research, such as addressing baseline characteristics and eligibility criteria that may affect outcomes, and addressing comparable impact based on the selection of control group conditions.

Most published studies examining effects of Tai Chi and/or Qigong on cancer-related fatigue have not established a measurable degree of fatigue as an eligibility criterion [[40], [41], [42], [43], [44], [45]], potentially missing the full strength of intervention effects on pre-existing fatigue (compared to studies where entry level fatigue may be negligible, attenuating results). Our prior pilot study on the effects of Tai Chi/Qigong (TCQ) set a requirement for a minimum of a low-moderate level of fatigue for study entry [5], resulting in significant improvements in fatigue.

Meditative movement studies may be further refined by designing control group conditions that include the physical activity and social connection components, while excluding the focus on meditative state and breathing rhythms. In our prior pilot study, we used an active control condition, Sham Qigong (SQG), designed to provide a similar level of activity and types of movements as TCQ and included social contact in the classes, but without a focus on the breath, or meditative centering. In this prior study, we found the SQG to have similar effects as TCQ on depression and sleep, purportedly brought about by the gentle exercise; even so, a significant improvement was found for fatigue in the TCQ group compared to SQG [5]. The current study, a three-arm randomized controlled trial (RCT), included the SQG comparison group, but also added a physically inactive control condition, education support (ES), to more clearly eliminate the potential of physical activity to confound results. All three conditions were delivered using in-person group contexts allowing group interaction and mutual support. For the current study, with measures to specifically assess fatigue, sleep, emotional distress (anxiety, depression), and cognitive function in BCSs, we tested the effects of the interventions:

Primary hypothesis: BCSs experiencing persistent cancer-related fatigue will experience greater reduction in fatigue with TCQ than with ES.

Secondary hypothesis: TCQ will improve factors associated with fatigue in BCSs, i.e., sleep quality, anxiety, depression, cognitive function, greater than ES.

Research question 1: Will SQG result in greater reduction in fatigue, sleep quality, anxiety, depression, and cognitive function than ES?

The purpose of this study was to test the effects of TCQ on fatigued BCSs compared to an inactive education support (ES) control condition and, further, to explore how a low-intensity physical activity intervention that includes similar movements to TCQ but without the focus on the breath and meditative state (SQG) compares to ES. These comparisons were designed to help understand the value of the unique meditative components of TCQ on fatigue and other symptoms, but also to assess the impact of the gentle exercise aspects of TCQ and SQG (in the comparison with the inactive ES).

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