Effect of one comprehensive education course to lower anxiety and depression among Chinese breast cancer patients during the postoperative radiotherapy period - one randomized clinical trial

一项综合教育课程对降低中国乳腺癌患者术后放疗期间焦虑和抑郁的影响——一项随机临床试验

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Abstract

BACKGROUND: We investigated the effectiveness of one education course to lower the severity of anxiety and depression symptoms among breast cancer (BC) patients during radiotherapy (RT). METHODS: All 290 one-sided BC patients were evenly randomized into intervention or control arm. "Intervention" patient was additionally provided with one three-hour course on psychological stresses and management skills. Changes of anxiety and depression score and their 3-level severity category ('normal', 'borderline' and 'abnormal' scored 0-7, 8-10 and 11-21, respectively) from HADS questionnaire over RT were evaluated by multivariable linear and ordinal logistic regressions. RESULTS: Response rates were 94 and 100% by "intervention" and "control" arm, respectively. Means of score changes by "intervention" and "control" (n = 145) were + 0.59 (SD = 2.47) and + 0.11 (SD = 2.55) for anxiety and + 0.81 (SD = 2.81) and + 0.45 (SD = 2.77) for depression scores, respectively. 'Abnormal' anxiety and depression patients were 4.1 and 6.9% at baseline and 4.8 and 6.9% at end of RT at 'control' arm; those rates were 6.6 and 7.4%, and 8.8 and 10.3% at 'intervention' arm, respectively. Both changes on anxiety and depression measurements between two arms were all insignificant (p > 0.20). CONCLUSIONS: One education course did not reduce the score and severity of anxiety and depression symptoms over RT period. TRIAL REGISTRATION: Chinese Clinical Trial Registry #: ChiCTR-IIR-16008818 at www.chictr.org.cn .

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