Efficacy of an inpatient yoga therapy program for cancer patients undergoing hematopoietic stem cell transplantation - Abstract Hematopoietic stem cell transplantation (HSCT) is a life-saving treatment, yet it is associated with a multitude of acute and chronic physical and psychological sequelae. The success of this treatment and survival for patients is related to the control of adverse effects of the transplantation. While clinical and biological parameters contribute to patient recovery and survival, research suggests the important role of psychosocial determinants such as stress, mental health, coping, and physical well-being on post-transplant recovery and survival. Therefore, prevention and early detection of symptoms is a high priority in the care of these patients, and yoga therapy may be an effective treatment. Yoga therapy (YT) is an evidence-based mind-body practice recommended for cancer to relieve nausea, fatigue, pain, sleep disruption, psychosocial distress, musculoskeletal symptoms, and cognitive dysfunction, all common symptoms experienced during HSCT. Yoga has also been associated with decreased cortisol response, increased cell-mediated immunity, and decreased pro-inflammatory biomarkers, all of which may lead to improved outcomes for those undergoing HSCT. However, few studies have investigated the efficacy and implementation of YT in an inpatient setting, and, besides our successful pilot study, none in patients undergoing HSCT. This randomized, semi-blinded, multicenter trial will evaluate the efficacy and explore the implementation of YT for patients undergoing HSCT (N=300). Patients will be randomly assigned to one of two groups: 1) a Yoga Therapy group (YT) or 2) an enhanced standard care (SC) group. YT patients will participate in yoga before, during hospitalization, and after discharge. The SC group includes available services provided in a standardized manner including the use of physical therapy support and walking support. The specific aims are to: 1) Examine the efficacy of YT relative to SC on HSCT-specific QOL; 2) Examine group differences in other patient-reported outcomes including general QOL and fatigue; 3) Explore group differences in psychosocial and functional outcomes and as possible mediators including stress, mental health (depression and anxiety), sleep disturbances, growth, self-efficacy, mindfulness, and objective functional measures as well as moderators of YT including demographic factors (sex, age, etc.), baseline psychosocial factors, and medical variables (e.g., autologous vs. allogeneic transplant); and 4) Explore YT’s implementation. After the proposed efficacy trial is completed, if YT is found clinically helpful to patients undergoing HSCT, the next phase will involve undertaking a large-scale implementation and dissemination study.
