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头颈部癌症患者的前瞻性纵向生活质量研究:一项纳入欧洲癌症研究与治疗组织核心生活质量问卷(EORTC QLQ-C30)的可行性研究

Prospective, longitudinal quality-of-life study of patients with head and neck cancer: a feasibility study including the EORTC QLQ-C30.

作者信息

Hammerlid E, Bjordal K, Ahlner-Elmqvist M, Jannert M, Kaasa S, Sullivan M, Westin T

机构信息

Department of Otolaryngology and Head and Neck Surgery, Sahlgrenska University Hospital, Göteborg University, Sweden.

出版信息

Otolaryngol Head Neck Surg. 1997 Jun;116(6 Pt 1):666-73. doi: 10.1016/S0194-59989770246-8.

Abstract

Despite modern advances in the treatment of head and neck cancer, the survival rate fails to improve. Considering the different treatment modalities involved, quality of life has been thought of as an additional end point criterion for use in clinical trials. A Nordic protocol to measure the quality of life of head and neck cancer patients before, during, and after treatment was established. Before the study, a pilot study was done with this protocol. The main purpose of this pilot study was to find out whether this cancer population would answer quality-of-life questionnaires repeatedly (six times) over a 1-year period and whether the chosen questionnaires-a core questionnaire (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)), a tumor-specific questionnaire, and a psychological distress measure (Hospital Anxiety and Depression scale (HAD))-were sensitive for changes to functions and symptoms during the study year. The results presented in this article all refer to the pilot study. Forty-eight consecutive patients agreed to participate in the study. The most common tumor locations were the oral cavity (17) and the larynx (12). Almost all patients received combined treatment: 45 of 48 radiation therapy, 18 of 48 chemotherapy, and 17 of 48 surgery. After the primary treatment, 40 patients had complete tumor remission. Four of the 48 patients did not answer any questionnaires and were therefore excluded from the study. Of the remaining 44 patients, 3 died during the study year, and another 6 withdrew for various reasons. Thirty-five (85%) of the 41 patients alive at the 1-year follow-up answered all six questionnaires and thus completed the study. Mailed questionnaires were used throughout the study. All questionnaires were well accepted and found to be sensitive to changes during the study year. The greatest variability was found for symptoms and functions related specifically to head and neck cancer. The symptoms were swallowing difficulties, hoarse voice, sore mouth, dry mouth, and problems with taste. They all showed the same pattern, with an increase of symptoms during and just after finishing the treatment. The HAD scale revealed a high level of psychological distress, with 21% probable cases of psychiatric morbidity at diagnosis. In conclusion, it was shown that the study design and questionnaires were feasible for the forthcoming prospective quality-of-life assessment of Swedish and Norwegian head and neck cancer patients.

摘要

尽管头颈部癌症的现代治疗取得了进展,但生存率并未提高。考虑到所涉及的不同治疗方式,生活质量已被视为临床试验中使用的一个额外终点标准。制定了一项北欧方案,用于测量头颈部癌症患者治疗前、治疗期间和治疗后的生活质量。在该研究之前,使用此方案进行了一项试点研究。这项试点研究的主要目的是了解该癌症人群是否会在1年的时间内多次(6次)回答生活质量问卷,以及所选问卷——一份核心问卷(欧洲癌症研究与治疗组织核心生活质量问卷(EORTC QLQ-C30))、一份肿瘤特异性问卷和一项心理困扰测量工具(医院焦虑抑郁量表(HAD))——在研究年度内对功能和症状的变化是否敏感。本文呈现的结果均来自该试点研究。48名连续的患者同意参与该研究。最常见的肿瘤部位是口腔(17例)和喉部(12例)。几乎所有患者都接受了综合治疗:48例中有45例接受了放射治疗,48例中有18例接受了化疗,48例中有17例接受了手术。在初始治疗后,40例患者肿瘤完全缓解。48例患者中有4例未回答任何问卷,因此被排除在研究之外。在其余44例患者中,3例在研究年度内死亡,另外6例因各种原因退出。在1年随访时存活的41例患者中有35例(85%)回答了所有6份问卷,从而完成了研究。在整个研究过程中使用了邮寄问卷。所有问卷都很容易被接受,并且发现对研究年度内的变化敏感。在与头颈部癌症特异性相关的症状和功能方面发现了最大的变异性。症状包括吞咽困难、声音嘶哑、口腔疼痛、口干和味觉问题。它们都呈现出相同的模式,即在治疗期间和刚结束治疗后症状会增加。HAD量表显示心理困扰程度较高,诊断时可能有21%的精神疾病发病率。总之,结果表明该研究设计和问卷对于即将进行的瑞典和挪威头颈部癌症患者的前瞻性生活质量评估是可行的。

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