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评估头颈部癌患者健康相关生活质量常规评估影响的随机试验

Randomized Trial Assessing the Impact of Routine Assessment of Health-Related Quality of Life in Patients with Head and Neck Cancer.

作者信息

Billa Oumar, Bonnetain Franck, Chamois Jérôme, Ligey Angeline, Ganansia Valérie, Noel Georges, Renard Sophie, Maillard Sophie, Quivrin Magali, Vulquin Noémie, Truntzer Pierre, Dabakuyo-Yonli Tienhan Sandrine, Maingon Philippe

机构信息

Georges-François Leclerc Cancer Centre-UNICANCER, Epidemiology and Quality of Life Unit, 21000 Dijon, France.

Lipids, Nutrition, Cancer Research Center, U1231 INSERM, 21000 Dijon, France.

出版信息

Cancers (Basel). 2021 Jul 29;13(15):3826. doi: 10.3390/cancers13153826.

DOI:10.3390/cancers13153826
PMID:34359726
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8345055/
Abstract

The impact of routine assessment of health-related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ-SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56-87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were reported to have a statistically significant increase in EQ VAS at 2 years ( < 0.0001) and exceeded the minimal clinically important difference (mean change at 2 years from baseline = 10.46). In the two arms, mean differences between arms were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for EQ VAS (mean change difference (MD) = 5.84), satisfaction with care, in particular waiting times (MD = 10.85) and satisfaction with accessibility (MD = 6.52). Routine assessment of HRQoL improves HRQoL and satisfaction with care for patients with HNC treated with radiotherapy.

摘要

评估了对头颈部癌(HNC)患者进行放疗时,健康相关生活质量(HRQoL)的常规评估对护理满意度及患者HRQoL的影响。HNC患者被随机分为两组,按性别、癌症部位和疾病分期进行分层。在干预组中,患者在随机分组前先完成欧洲癌症研究与治疗组织(EORTC)QLQ-C30和EORTC QLQ-H&N35问卷,然后在放疗期间(7周)每次就诊前完成,之后每3个月完成一次,直至1年,此后在2年时完成。在对照组中,EORTC QLQ-C30和EORTC QLQ-H&N35问卷在随机分组前以及此后1年和2年时完成。主要终点是根据欧洲生活质量调查问卷(EuroQol)的EQ VAS评估,从基线到2年时HRQoL评分的平均变化。次要终点是根据QLQ-SAT32评估,从基线到2年时护理满意度的平均变化。200名头颈部癌患者参与了本研究(平均年龄58.83岁(范围36.56 - 87.89岁)),其中100名被分配到干预组,100名被分配到对照组。据报告,干预组患者在2年时EQ VAS有统计学显著增加(<0.0001),且超过了最小临床重要差异(从基线到2年的平均变化 = 10.46)。在两组中,组间平均差异无统计学显著性,但在EQ VAS方面发现有利于干预组的最小临床重要差异(平均变化差异(MD) = 5.84),在护理满意度方面,特别是等待时间(MD = 10.85)和可及性满意度(MD = 6.52)。对接受放疗的HNC患者进行HRQoL的常规评估可改善其HRQoL和护理满意度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/037c/8345055/2ac356109d77/cancers-13-03826-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/037c/8345055/5c6bed05a1fe/cancers-13-03826-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/037c/8345055/2ac356109d77/cancers-13-03826-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/037c/8345055/5c6bed05a1fe/cancers-13-03826-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/037c/8345055/2ac356109d77/cancers-13-03826-g002.jpg

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