Purpose

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.

Conclusion

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.

Trial registration

This trial is registered with ClinicalTrials.gov No. NCT00297791

中文翻译：

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开发直肠癌治疗患者全球健康相关生活质量的多变量预测模型：在五个国家进行的前瞻性研究

目的

直肠癌及其治疗会对健康相关的生活质量 (HRQoL) 产生负面影响。如果能够及早（最好是在开始治疗之前）识别持续低 HRQoL 的危险因素，则可以识别并实施个体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 个月整体 HRQoL 的多变量预测模型。

方法

COLOR II 是一项腹腔镜和开腹直肠癌手术的随机、多中心国际试验，其中一项关于 HRQoL 的子研究纳入了来自 5 个国家 12 家医院的 385 名患者。 HRQoL 研究对于 COLOR II 试验中的医院来说是可选的。在术前以及术后 1 个月和 12 个月时分析 EORTC QLQ-C30 和 EORTC QLQ-CR38。在探索性分析中，研究了年龄、性别、疲劳、疼痛、ASA 分类、并发症和术后症状与 HRQoL 之间的相关性。双变量初始分析之后是多元回归模型。

结果

患者特征和临床因素解释了 4-10% 的全球 HRQoL 差异。 EORTC QLQ-C30 患者报告的结果解释了全球 HRQoL 差异的 55-65%。主要预测因素是疲劳和疼痛，它们对所有测量时间点的总体 HRQoL 产生显着影响。

结论

我们发现，疲劳和疼痛是与接受直肠癌 T1-T3 Nx 治疗的患者治疗后总体 HRQoL 相关的两个重要因素。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。

试用注册

该试验已在 ClinicalTrials.gov 注册，注册号为 NCT00297791