4.Validity of the Japanese version of functional assessment of cancer therapy-gastric (FACT-Ga) and its sensitivity to ascites volume change: a retrospective analysis of Japanese clinical trial participants.
4.Validity of the Japanese version of functional assessment of cancer therapy-gastric (FACT-Ga) and its sensitivity to ascites volume change: a retrospective analysis of Japanese clinical trial participants.
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4.日本版癌症治疗功能评估-胃（FACT-Ga）的有效性及其对腹水量变化的敏感性：对日本临床试验参与者的回顾性分析。
DOI：
10.1007/s00520-016-3290-3
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发表时间：
2016
影响因子：
3.1
通讯作者：
Morita S
中科院分区：
文献类型：
--
作者：
Maeda H;Sato M;Kobayashi M;Takiguchi N;Yoshikawa T;Yoshino S;Yoshida K;Tsuburaya A;Sakamoto J;Morita S
目的设计胃癌治疗功能评估量表（FACT-Ga），评价胃癌患者的生活质量。我们的目的是探讨的信度和效度的FACT-Ga在日本患者，并评估灵敏度的胃癌子量表检测变化的癌症相关变量随着时间的推移。MethodsThe日本版的FACT-Ga被使用，数据来自日本患者谁参加了两个临床试验：晚期胃癌或复发性胃癌合并腹水的治疗（晚期胃癌组），或胃癌根治性切除术后的辅助化疗（辅助组）。心理测量数据，包括用于确定可靠性，内部一致性和临床有效性的数据进行了分析。通过比较两组患者的子量表评分以及比较不同体力状态评分患者的子量表评分来评估临床有效性。胃癌子量表评分和胃癌相关变量之间的相关性也进行了研究。此外，胃癌子量表的腹水量，腹围，和东部肿瘤协作组（ECOG）的性能状态（PS）的变化的敏感性进行了检查，通过评估其相关性在先进的GC group.ResultsWe收集了156例患者（62先进的GC组患者和94辅助组患者）的数据。两组在大多数时间点的子量表应答率均超过80%。Cronbach系数α显示每个分量表具有良好的内部一致性。基线时，辅助治疗组的QOL评分高于晚期胃癌组（P< 0.05），不同体力状态评分的患者QOL评分差异有统计学意义。胃癌子量表评分的变化与腹水量的变化具有统计学显著相关性（斯皮尔曼等级相关系数为0.5;P< 0.05）。与腹水量变化相关的QOL变化的检测表明其可以更广泛地使用; FACT-Ga评分可以用作胃癌相关腹水患者的终点。
PurposeThe functional assessment of cancer therapy-gastric (FACT-Ga) questionnaire was designed to evaluate quality of life (QOL) in patients with gastric cancer. We aimed to explore the reliability and validity of FACT-Ga in Japanese patients, and assess the sensitivity of the gastric cancer subscale for detecting changes in cancer-related variables over time.MethodsThe Japanese version of FACT-Ga was used, and data were obtained from Japanese patients who participated in either of two clinical trials: treatment for advanced or recurrent gastric cancer with ascites (advanced-GC group), or adjuvant chemotherapy after curative resection of gastric cancer (adjuvant group). Psychometric data including data used to determine reliability, internal consistency, and clinical validity were analyzed. Clinical validity was evaluated by comparing subscale scores for patients in the two groups, and by comparing subscale scores for patients with different performance status scores. Correlation between gastric cancer subscale scores and gastric cancer-related variables was also examined. In addition, sensitivity of the gastric cancer subscale to changes in ascites volume, abdominal girth, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) was examined by evaluating their correlation in the advanced-GC group.ResultsWe collected data on 156 patients (62 advanced-GC group patients and 94 adjuvant group patients). Response rates for the subscales were over 80 % at most time points for both the groups. Cronbach’s coefficient alpha revealed good internal consistency for each subscale. At baseline, the adjuvant group had higher QOL scores than the advanced-GC group (P< 0.05), and QOL scores for patients with different performance status scores differed significantly. Changes in gastric cancer subscale scores showed statistically significant correlation with changes in ascites volume (Spearman’s rank correlation coefficient, 0.5;P< 0.05).ConclusionsFACT-Ga is reliable and clinically valid for Japanese patients with gastric cancer. Detection of QOL changes that correlate with ascites volume changes suggests that it could be used more broadly; FACT-Ga scores could be used as an endpoint for patients with gastric cancer-related ascites.