BACKGROUND The incidence of head and neck cancer is increasing slightly. Head and neck cancer but also it's necessary and often successful treatment may affect general domains of health-related quality of life and provoke a variety of adverse symptoms and side effects, both during and after treatment. The objective of this study was to compare a person-centred care intervention in terms of health-related quality of life, disease-specific symptoms or problems, with traditional care as a control group for patients with head and neck cancer. METHODS In this randomized controlled trial, person-centred-care intervention and traditional care (control) groups comprised 54 and 42 patients, respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of treatment. The questionnaires' scores were compared between groups by using independent samples test and non-parametric test for continuous variables. For categorical data, Fisher's exact test was used. Longitudinal data were analysed using generalized linear models for normally distributed repeated measures data. RESULTS At baseline, the intervention and control groups were comparable in terms of medical and sociodemographic variables, clinical characteristics, health-related quality of life and disease-specific symptoms or problems. At all the follow-up points, even during the worst period for the patients, the person-centred-care group consistently reported better scores than the control group. The differences were numerically but not always statistically significant. When testing longitudinal data, statistically significant results were found for head and neck cancer-specific problems, swallowing (p = 0.014), social eating (p = 0.048) and feeling ill (p = 0.021). CONCLUSIONS The results from this study suggest that adopting the person-centred-care concept practiced here could be a way to improve function and wellbeing in patients with head and neck cancer. TRIAL REGISTRATION The study was retrospectively registered in 2016-12-05 in Clinical Trials gov. "Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer" registration number: NCT02982746.

中文翻译：

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以人为中心的护理干预能否改善头颈癌患者的健康相关生活质量？一项随机对照研究。

背景技术头颈癌的发病率略有增加。头颈癌也很必要，而且经常成功的治疗可能会影响与健康相关的生活质量的一般领域，并在治疗期间和之后引发各种不良症状和副作用。这项研究的目的是比较以人为中心的护理干预措施在健康相关的生活质量，特定疾病的症状或问题方面的优势，并以传统护理作为头颈癌患者的对照组。方法在这项随机对照试验中，以人为中心的护理干预组和传统护理（对照组）组分别包括54例和42例患者。使用的结果度量为：EORTC QLQ-C30和EORTC QLQ-C35。两组都在基线以及4、10，从治疗开始的18和52周。通过使用独立样本检验和非参数检验对连续变量进行比较，比较了各组问卷的得分。对于分类数据，使用Fisher精确检验。纵向数据使用广义线性模型对正态分布重复测量数据进行分析。结果基线时，干预组和对照组在医学和社会人口统计学变量，临床特征，与健康有关的生活质量以及与疾病有关的症状或问题方面具有可比性。在所有的随访过程中，即使在患者最差的时期，以人为中心的护理组也始终表现出比对照组更好的评分。差异在数值上却并不总是统计学上显着的。在测试纵向数据时，在针对头颈癌的特定问题，吞咽（p = 0.014），社交饮食（p = 0.048）和感觉不适（p = 0.021）方面，发现了具有统计学意义的结果。结论从这项研究的结果表明，采用此处实践的以人为本的护理概念可能是改善头颈癌患者功能和健康的一种方法。试验注册该研究于2016-12-05年在Clinical Trials gov中进行了回顾性注册。“可以进行以人为中心的护理干预来改善头颈癌患者的健康相关生活质量”注册号：NCT02982746。结论从这项研究的结果表明，采用此处实践的以人为本的护理概念可能是改善头颈癌患者功能和健康的一种方法。试验注册该研究于2016-12-05年在Clinical Trials gov中进行了回顾性注册。“可以进行以人为中心的护理干预来改善头颈癌患者的健康相关生活质量”注册号：NCT02982746。结论从这项研究的结果表明，采用此处实践的以人为本的护理概念可能是改善头颈癌患者功能和健康的一种方法。试验注册该研究于2016-12-05年在Clinical Trials gov中进行了回顾性注册。“可以进行以人为中心的护理干预来改善头颈癌患者的健康相关生活质量”注册号：NCT02982746。