Abstract
Abstract Background: Psychological and physical distress is high in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy. The ***patients'ability to cope with this distress has an impact on treatment variables, i.e. deliverable chemotherapy dose, tolerabilty of side effects, and finaly treatment completion rate. Exercise intervention studies have shown physiological and psychological benefits when undertaken during cancer treatment. There is also evidence that mind/body interventions such as yoga are useful to manage treatment-related symptoms and anxiety in breast cancer patients. Considering the specific theoretical background of mind/body interventions this ongoing trial aims to elucidate the different effects of yoga and conventional exercise on physical and psychological factors in breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy. Trial design: Longitudinal data collection within an open, prospective, randomized trial using standardized questionnaires about inner correspondence and peacefulness with practices (ICPH), health-related quality of life (EORTC QLC C-30), fatigue (Cancer Fatigue Scale, CFS-D), mindfulness (Freiburg Mindfulness Inventory, FMI), spiritual/religious attitudes and disease coping (SpREUK), and life satisfaction (Brief Multidimensional Life Satisfaction Scale, BMLSS). Patients with newly diagnosed stage I-III breast cancer undergoing neoadjuvant or adjuvant chemotherapy are randomly assigned to receive yoga or conventional exercise on a 1:1 ratio. The yoga intervention consists of a weekly 60-minute Iyengar-Yoga group-session together with individual home-based, selfcontained 20-minute sessions twice a week. The conventional exercise intervention consists of a weekly 60-minute physiotherapy exercise session together with individual home-based, selfcontained 20-minute sessions twice a week. Data assessments via questionnaires are done at baseline, right after the 12-week intervention period and 2 months after the end of intervention. Statistical analysis includes analysis of variance with all collected parameters and analysis of correlation between ICPH and above parameters. For statistical power 1-β=0.8 and twosided probability of error a=0.05 the target accrual is 120 patients. Patient accrual within two breast care units started in April 2011 with 12 patients being on study to date (2011, June 21). Planned period of accrual is 20 months. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT3-02-02.
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