PDF(Pubmed)
Abstract：
OBJECTIVE: Rectal cancer and its treatment have a negative impact on health-related quality of life (HRQoL). If risk factors for sustained low HRQoL could be identified early, ideally before the start of treatment, individualised interventions could be identified and implemented to maintain or improve HRQoL. The study aimed to develop a multivariable prediction model for global HRQoL 12 months after rectal cancer treatment.
METHODS: Within COLOR II, a randomised, multicentre, international trial of laparoscopic and open surgery for rectal cancer, a sub-study on HRQoL included 385 patients in 12 hospitals and five countries. The HRQoL study was optional for hospitals in the COLOR II trial. EORTC QLQ-C30 and EORTC QLQ-CR38 were analysed preoperatively and at 1 and 12 months postoperatively. In exploratory analyses, correlations between age, sex, fatigue, pain, ASA classification, complications, and symptoms after surgery to HRQoL were studied. Bivariate initial analyses were followed by multivariate regression models.
RESULTS: Patient characteristics and clinical factors explained 4-10% of the variation in global HRQoL. The patient-reported outcomes from EORTC QLQ-C30 explained 55-65% of the variation in global HRQoL. The predominant predictors were fatigue and pain, which significantly impacted global HRQoL at all time points measured.
CONCLUSIONS: We found that fatigue and pain were two significant factors associated with posttreatment global HRQoL in patients treated for rectal cancer T1-T3 Nx. Interventions to reduce fatigue and pain could enhance global HRQoL after rectal cancer treatment.
BACKGROUND: This trial is registered with ClinicalTrials.gov No. NCT00297791.
METHODS: Within COLOR II, a randomised, multicentre, international trial of laparoscopic and open surgery for rectal cancer, a sub-study on HRQoL included 385 patients in 12 hospitals and five countries. The HRQoL study was optional for hospitals in the COLOR II trial. EORTC QLQ-C30 and EORTC QLQ-CR38 were analysed preoperatively and at 1 and 12 months postoperatively. In exploratory analyses, correlations between age, sex, fatigue, pain, ASA classification, complications, and symptoms after surgery to HRQoL were studied. Bivariate initial analyses were followed by multivariate regression models.
RESULTS: Patient characteristics and clinical factors explained 4-10% of the variation in global HRQoL. The patient-reported outcomes from EORTC QLQ-C30 explained 55-65% of the variation in global HRQoL. The predominant predictors were fatigue and pain, which significantly impacted global HRQoL at all time points measured.
CONCLUSIONS: We found that fatigue and pain were two significant factors associated with posttreatment global HRQoL in patients treated for rectal cancer T1-T3 Nx. Interventions to reduce fatigue and pain could enhance global HRQoL after rectal cancer treatment.
BACKGROUND: This trial is registered with ClinicalTrials.gov No. NCT00297791.
摘要：
目的：直肠癌及其治疗对健康相关生活质量（HRQoL）有负面影响。如果可以及早发现持续低HRQoL的风险因素，理想情况下是在治疗开始之前，可以确定并实施个性化干预措施以维持或改善HRQoL。该研究旨在开发直肠癌治疗后12个月全球HRQoL的多变量预测模型。
方法：在颜色II中，一个随机的，多中心,腹腔镜和开腹直肠癌手术的国际试验，一项关于HRQoL的子研究包括12家医院和5个国家的385名患者.在COLORII试验中，HRQoL研究对于医院是可选的。术前、术后1个月和12个月对EORTCQLQ-C30和EORTCQLQ-CR38进行分析。在探索性分析中，年龄之间的相关性，性别,疲劳,疼痛,ASA分类，并发症,并对HRQoL术后症状进行了研究。双变量初始分析之后是多变量回归模型。
结果：患者特征和临床因素解释了4-10%的整体HRQoL变化。来自EORTCQLQ-C30的患者报告结果解释了全球HRQoL变化的55-65%。主要的预测因素是疲劳和疼痛，在所有测量的时间点显著影响全球HRQoL。
结论：我们发现疲劳和疼痛是直肠癌T1-T3Nx患者治疗后整体HRQoL的两个显著相关因素。减少疲劳和疼痛的干预措施可以提高直肠癌治疗后的整体HRQoL。
背景：该试验已在ClinicalTrials.govNo.NCT00297791。
方法：在颜色II中，一个随机的，多中心,腹腔镜和开腹直肠癌手术的国际试验，一项关于HRQoL的子研究包括12家医院和5个国家的385名患者.在COLORII试验中，HRQoL研究对于医院是可选的。术前、术后1个月和12个月对EORTCQLQ-C30和EORTCQLQ-CR38进行分析。在探索性分析中，年龄之间的相关性，性别,疲劳,疼痛,ASA分类，并发症,并对HRQoL术后症状进行了研究。双变量初始分析之后是多变量回归模型。
结果：患者特征和临床因素解释了4-10%的整体HRQoL变化。来自EORTCQLQ-C30的患者报告结果解释了全球HRQoL变化的55-65%。主要的预测因素是疲劳和疼痛，在所有测量的时间点显著影响全球HRQoL。
结论：我们发现疲劳和疼痛是直肠癌T1-T3Nx患者治疗后整体HRQoL的两个显著相关因素。减少疲劳和疼痛的干预措施可以提高直肠癌治疗后的整体HRQoL。
背景：该试验已在ClinicalTrials.govNo.NCT00297791。
