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II期乳腺癌患者的生活质量:一种用于临床试验的工具。

Quality of life in stage II breast cancer: an instrument for clinical trials.

作者信息

Levine M N, Guyatt G H, Gent M, De Pauw S, Goodyear M D, Hryniuk W M, Arnold A, Findlay B, Skillings J R, Bramwell V H

机构信息

Ontario Cancer Treatment and Research Foundation, Hamilton Regional Cancer Centre, Canada.

出版信息

J Clin Oncol. 1988 Dec;6(12):1798-810. doi: 10.1200/JCO.1988.6.12.1798.

DOI:10.1200/JCO.1988.6.12.1798
PMID:3058874
Abstract

A questionnaire has been developed for use as an outcome measure in clinical trials of adjuvant chemotherapy in women with stage II breast cancer. The selection of items for this Breast Cancer Chemotherapy Questionnaire (BCQ) was based on the problems and experiences felt to be most important by women undergoing adjuvant chemotherapy. The BCQ consists of 30 questions that focus on loss of attractiveness, fatigue, physical symptoms, inconvenience, emotional distress, and feelings of hope and support from others. The BCQ, other instruments that evaluate quality-of-life (Spitzer, Karnofsky, and Rand), and patient and physician global assessments were administered serially to 418 patients taking part in a randomized trial comparing a 12-week regimen and a 36-week regimen of adjuvant chemotherapy. The validity of the BCQ is supported by its correlation with the Rand Emotional (r = .58), Rand Physical (r = .60), and Spitzer (r = .62) questionnaires. The BCQ correlated more strongly with global ratings of both physical and emotional function by the patients and their physicians than the other instruments. A comparison of the quality-of-life outcomes of patients in the two treatment groups in the period beyond 3 months after initiation of treatment, when one group had completed the treatment course and the other was still on treatment, revealed that the BCQ and Karnofsky were the only instruments able to demonstrate differences between the groups (P less than .0001). Hence, the BCQ is a valid and responsive method of assessing treatment-related morbidity in patients receiving adjuvant chemotherapy for stage II breast cancer.

摘要

已开发出一份调查问卷,用作II期乳腺癌女性辅助化疗临床试验的结果衡量指标。这份乳腺癌化疗调查问卷(BCQ)的项目选取基于接受辅助化疗的女性认为最为重要的问题和经历。BCQ包含30个问题,聚焦于吸引力丧失、疲劳、身体症状、不便、情绪困扰以及他人给予的希望感和支持感。对参与一项随机试验的418名患者连续进行BCQ、其他评估生活质量的工具(斯皮策、卡诺夫斯基和兰德量表)以及患者和医生整体评估,该随机试验比较了为期12周和36周的辅助化疗方案。BCQ与兰德情绪问卷(r = 0.58)、兰德身体问卷(r = 0.60)和斯皮策问卷(r = 0.62)的相关性支持了BCQ的有效性。与其他工具相比,BCQ与患者及其医生对身体和情绪功能的整体评分的相关性更强。对治疗开始3个月后两个治疗组患者的生活质量结果进行比较,此时一组已完成治疗疗程而另一组仍在接受治疗,结果显示BCQ和卡诺夫斯基量表是仅有的能够显示两组之间差异的工具(P小于0.0001)。因此,BCQ是评估接受II期乳腺癌辅助化疗患者治疗相关发病率的一种有效且灵敏的方法。

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