Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study.

Introduction: Breast cancer is by far the most common form of cancer diagnosis in women. Cancer treatments are long, complex and often cumbersome with numerous side effects. Fatigue is now considered as the most distressing side effect of treatment. Fifty-eight percent to 94% of breast cancer patients experience fatigue during treatment with adjuvant chemotherapy.
Objective: The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effects of the different adjuvant treatments will be explored.
Research Design: A prospective longitudinal study in women diagnosed for the first time with stage I-IIIA breast cancer and who have undergone surgery, has been designed to meet the study aims. Recruitment began in September 2008 and target enrollment completion date is December 2010. (clinicaltrials.gov number, NCT01064427). The MFI-20 (Multidimensional Fatigue Inventory) and the EORTC QLQ-C30 (European Organization for Research and Treatment Quality of Life Questionnaire) will be completed, at several times. The follow-up is planned over a 24-month period. We studied adjuvant chemotherapy regimens with anthracyclines or with anthracycline/taxane combination. The LOR (Life Orientation Test) will be completed only at baseline to estimate the level of optimism of the patient and the STAI (State-Trait Anxiety Questionnaire) will be filled to measure a stable propensity to experience anxiety, and tendencies to perceive stressful situations as threatening.
Outcomes: The knowledge of determinants should facilitate screening of fatigue, and its evaluation on consequences on the patients' quality of life would allow physicians better help patients cope with the management of fatigue according to the adjuvant regimen.
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