A safety evaluation of chemotherapy is performed by CTCAE. It is the evaluation by health care workers, and distress evaluation by patient himself is not included in it. Therefore, a health care worker underestimates patients' distress. This study was carried out to identify the patients' characteristics underlying differences between safety evaluation and distress evaluation. The patients who met the criteria were 72 in number. They were divided into 2 groups. Group A(17 patients)included patients who demonstrated difference between safety evaluation and distress evaluation. Group B(55 patients)included patient who did not show difference between safety evaluation and distress evaluation. The patients who visited a hospital were evaluated for QOL, depression screening, CTCAE(safety evaluation), and PRO-CTCAE(distress evaluation). A meaningful difference was observed between depression screening, QOL-ACD(physical status, psychological status, face scale, and total), and the number of items of side effect by PRO-CTCAE through a univariate analysis. A meaningful difference was observed for QOL-ACD(physical)in logistic regression analysis(odds ratio=1.47, p=0.013). It is suggested that having physical distress reflected by the QOL evaluation before chemotherapy results in the difference between safety evaluation and distress evaluation.
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