Quality of life during clinical trials: conceptual model for the Lung Cancer Symptom Scale (LCSS)

To appreciate the full benefits of treatment for lung cancer, especially in trials that fail to show improvements in survival, data recording the quality of life must be captured and refined to produce meaningful information. A conceptual model for quality of life for lung cancer patients was tested to obtain information about the dimensions of the quality-of-life construct for ongoing development and testing of a subjective measure for clinical trials. Using a longitudinal study design, the stability of predictive factors of the physical and functional dimensions of quality of life were examined using regression analysis. A patient-rated quality-of-life measure, the Lung Cancer Symptom Scale (LCSS), was administered to 144 non-smallcell lung cancer patients at baseline, day 29, and day 71 of a chemotherapy trial. The range of explained variance for all three components of the lung cancer model over three assessment points was as follows: symptomatic distress 41%–53%, activity status 48%–52%, and overall quality of life 35%–53%. The three dimensions fluctuated slightly during intervention, but were relatively stable factors across all three times of evaluation. The LCSS model explained nearly half of the variance for quality of life experienced by lung cancer patients during therapy with a new chemotherapeutic agent. These findings provide support that the physical and functional dimensions are important predictors of quality of life for individuals with lung cancer. Meaningful subjective quality-of-life data can be obtained to evaluate an intervention by using a disease-and sitespecific quality-of-life measure for individuals with lung cancer, based on a reproducible conceptual model such as the LCSS, which is suitable for serial measurement for the progressive disease of lung cancer.     

Assessing quality of life following neoadjuvant therapy for early stage non-small cell lung cancer (NSCLC): results from a prospective analysis using the Lung Cancer Symptom Scale (LCSS)

Background  The assessment of the impact of neoadjuvant therapy on quality of life (QL) has rarely been prospectively planned and evaluated, although validated QL instruments are available—such as the Lung Cancer Symptom Scale (LCSS) used in this study. The modest but significant survival gains reported with neoadjuvant and adjuvant approaches need to be viewed in terms of the added risks and toxicities associated with two or three modalities of treatment. Materials and methods  The objective was to compare patient-determined QL ratings from baseline (prior to neoadjuvant chemotherapy) with those in subsequent months of follow-up. All patients had clinical stage I or II non-small cell lung cancer (NSCLC) and participated in one of two similar randomized protocols. Patients received preoperative chemotherapy (three cycles) of gemcitabine plus carboplatin or paclitaxel in one trial or gemcitabine plus carboplatin or cisplatin in the second. Patients completed the LCSS at baseline, every 3 weeks preoperatively, and every 3 months postoperatively up to 12 months. Results  Full QL data are available for 43 patients with at least one postsurgical evaluation and for 23 patients with evaluation at 1-year postsurgery. In patients with at least one postsurgical evaluation, 84% had an ECOG performance status of 0, 93% had a complete resection, and 67% (95% CI = 52, 81) of patients experienced improved or stable symptoms. A subgroup of patients (14 of 43) reported worsening of QL (33%). These patients experienced a mean worsening of 66% in individual symptom parameters, with an average of seven of nine LCSS symptom parameters declining. Conclusions  Most patients reported improved or stable QL. Prospectively planned QL assessment is feasible with neoadjuvant trials and adds useful information not otherwise attainable. Preliminary data were previously presented at the American Society of Clinical Oncology (ASCO) meeting in 2005.     

Measuring quality of life in patients with pleural mesothelioma using a modified version of the Lung Cancer Symptom Scale (LCSS): psychometric properties of the LCSS-Meso

Health-related quality of life (QOL) assessment is a key component in patient assessment and the development of therapies for malignant pleural mesothelioma. However, no mesothelioma-specific instrument was available. The Lung Cancer Symptom Scale (LCSS), a site-specific instrument used to assess QOL in patients with lung cancer, was identified as an instrument that could be appropriate. A modified nine-item patient-reported and six-item observer-reported LCSS was incorporated into two clinical trials of pemetrexed in patients with pleural mesothelioma. Basic psychometric properties of feasibility, reliability, and validity were tested. Properties were stable or enhanced by deletion of the hemoptysis item. Feasibility was demonstrated with a high completion rate of 90% by 512 patients. Reliability was acceptable, with good internal consistency for the eight-item measure (alpha coefficient=0.86) and reasonably good for the five-item observer measure (alpha coefficient=0.66); there was also good stability for the patient measure using test–retest (r=0.87). Content validity was supported by a literature review and patient self-report of presenting symptoms (>90% of patients had three or more symptoms). Construct validity was well supported by finding better scores in the higher performance status groups and greater symptom improvement in patients with tumor response, good concordance with the LCSS conceptual model and good explanation of variance for summation items, and a high degree of convergence between the patient and observer forms (r=0.57). Criterion-related validity was supported by predicting survival time, time to progression, and tumor response rate; all three summary items and the total LCSS-Meso score were statistically significant predictors (p<0.005). The LCSS-Meso is a feasible, reliable, and valid instrument to assess health-related QOL in patients with pleural mesothelioma. One item, hemoptysis, was dropped from the original LCSS based on these findings.     

Symptom clusters and quality of life in Chinese patients with heart failure

BackgroundEffective symptom assessment and management can improve quality of life in patients with heart failure. However, how psychological symptom cluster, physical symptom cluster and heart failure symptom cluster influence the quality of life of patients with heart failure remains unknown.Aims(a) To describe the symptom clusters among Chinese patients with heart failure (HF), (b) explore the relationship between symptom clusters and quality of life (QOL), and (c) detect if physical and psychological symptoms are mediators of the association between heart failure symptom and QOL.MethodsThree hundred and one patients with heart failure completed measures of symptom (MSAS), QOL and demographic and clinical characteristics. Multiple regression analysis was used to analyse the data.FindingsThe mean age of participants was 72.19 years (range 31–96 years). Each patient was approximately accompanied by an average of 11.19 symptoms (range 0–31), and the top six most common symptoms of Chinese HF patients were shortness of breath, difficulty sleeping, difficulty breathing when lying flat, lack of energy, lack of appetite and cough. Both physical symptom cluster and psychological symptom cluster were the mediators of the relationship between heart failure symptom cluster and QOL.ConclusionsThere were mediating effects of physical symptom cluster and psychological symptom cluster between heart failure symptom cluster and QOL in Chinese patients with HF. Operative assessment, management and alleviation of physical symptoms and psychological symptoms should be prioritised in symptom management strategies for the clinical caregivers.     

肺癌患者的症状群及影响因素研究

目的 调查肺癌患者疾病进展和治疗过程中的相关症状,探讨患病人群的症状群种类及其影响因素.方法 采用中文版安德森症状评估量表(Chinese version of the M.D.Anderson symptom inventory,MDASI-C)、修订版肺癌症状模块对住院肺癌患者进行调查.结果 2012年8～12月共180例患者完成调查,结果显示肺癌患者普遍存在多种症状,其中以睡眠不安、疲乏、食欲下降、疼痛、气短和胸闷最为严重.探索性因子分析得出4个症状群,分别为疾病行为症状群、肺癌特异性症状群、上消化道症状群、呼吸系统症状群.多元直线回归显示功能状态、伴随疾病数量和正在接受的治疗是症状群严重程度的影响因素.结论 肺癌患者存在多种症状群,从症状群角度对患者进行症状管理,能够产生更好的临床效果,从而提高患者的生存质量.     

Symptom profiles and palliative care in advanced pancreatic cancer—a prospective study

Objectives To describe prospectively the prevalence and severity of disease-related symptoms, quality of life (QOL) and need for palliative care in patients with advanced pancreatic cancer.Patients and methods Fifty-one patients treated for advanced pancreatic cancer filled in the Edmonton Symptom Assessment Scale (ESAS) for symptom registration and the EORTC QLQ-C30 and QLQ-PAN26 quality of life questionnaires at first contact (baseline) and the ESAS in the following consultations. Need for palliative interventions were registered.Results Of the 22 women and 29 men (mean age, 62 years), 20 had locally unresectable cancer, 19 had metastatic disease, and 12 had recurrent disease after curative resection. Forty-six patients died during follow-up (median survival, 99 days). At baseline, patients reported significantly impaired QOL on nine of 15 scales/items (p<0.01) relative to the general population. Fatigue, loss of appetite, and impaired sense of well-being were the most troublesome symptoms on the ESAS, measured to 4.4(±2.8)/5.3(±2.3), 4.4(±3.2)/5.9(±2.7), and 4.0(±2.9)/4.6(±2.7) (mean±SD) at baseline and 8 weeks before death, respectively. Forty-four of the 51 (86%) initial consultations and 107 (58%) of the 185 follow-ups (124 clinical and 61 phone-calls) resulted in palliative care interventions, most frequently changes in opioid or laxative medication and dietary advice.Conclusions Patients with advanced pancreatic cancer develop several distressing symptoms. ESAS was useful for assessment of symptom prevalence and intensity and is a clinically adequate method for symptom control. A multidisciplinary approach is necessary for the best palliation of symptoms at the time of diagnosis and during follow-up.     

Factors correlated with fatigue in disease-free breast cancer patients: application of the Cancer Fatigue Scale

 Fatigue is one of the most frequent symptoms in cancer patients. However, the precise causes of this fatigue are still unknown, and this situation makes it difficult to combat the problem. The present study was conducted to investigate factors correlated with fatigue in disease-free breast cancer patients. A group of 134 randomly selected ambulatory breast cancer patients who had undergone successful surgical treatment participated. They completed the Cancer Fatigue Scale, the Hospital Anxiety and Depression Scale, the Mental Adjustment to Cancer Scale, and an ad hoc questionnaire detailing physical symptoms, social support, and demographic variables at home and returned them by mail the following day. Multiple regression analysis revealed that fatigue was significantly correlated with dyspnea, insufficient sleep, and depression, and that these three variables accounted for a total of 46% of variance in fatigue. Factors concerned with the cancer and treatment, such as disease stage, lymph node metastasis, number of days since operation, past intravenous chemotherapy, radiotherapy, current use of fluoropyrimidine compounds, and current use of tamoxifen citrate were not correlated with fatigue. The results suggest that fatigue in this population is determined by current physical and psychological distress rather than by the cancer itself and prior cancer treatments, and that the management of dyspnea, insomnia, and depression might be important in reducing fatigue in this population. Published online: 17 January 2000     

口腔癌术后患者症状群与生活质量的相关性研究

目的:调查口腔癌患者治疗过程中的症状,探讨症状群种类及其与生活质量的相关性。方法:采用便利抽样法,选取某三级甲等医院口腔癌术后患者201例为研究对象,应用头颈癌安德森症状评估量表、华盛顿生活质量测评量表对其进行调查,分析二者相关性。结果:189例患者完成了问卷调查。口腔癌术后患者在疾病进展和治疗过程中存在多种症状,较严重的症状有吞咽咀嚼和发声讲话症状。探索性因子分析得出3个症状群,分别为口腔咽喉症状群、困倦-消化道症状群、疲劳-呼吸症状群。生存质量各维度得分及总分与3个症状群总分之间呈负相关(P<0.05)。结论:口腔癌患者在术后康复过程中存在影响生活质量的多个症状群,并且严重影响患者的生存质量。医护人员应把握这一特点,及时评估症状,积极管理症状群,提高患者的生存质量。     

肺癌生存者自我管理行为评估量表的编制及信效度检验

目的 编制肺癌生存者自我管理行为评估量表,并检验其信效度。 方法 以自我管理理论为指导,在文献分析及半结构式访谈的基础上,通过德尔菲专家函询、小组讨论和预调查形成量表初稿,便利选取2021年4月— 10月浙江省某三级甲等综合医院和肿瘤专科医院564例肺癌生存者进行问卷调查,检验量表的信效度。 结果 正式量表共包括日常生活管理、症状管理、随访管理、信息与资源管理、情绪管理和希望管理6个维度,47个条目。量表总的Cronbach’s α系数为0.950,分半信度系数为0.756。内容效度指数为0.966,结构效度KMO值为0.926,共提取6个公因子,累计方差贡献率为63.546%。 结论 构建的肺癌生存者自我管理行为评估量表具有良好的信效度,适用于肺癌生存者自我管理行为的评估。     

Cancer patients and their network: the meaning of the social network and social interactions for quality of life

A lot of research is carried out on the subject of social relations and quality of life. One should find at least some indication for an association between the social environment and quality of life of cancer patients; will interventions be appropriate and well-considered? But until now, less has been known about the association between the social network of cancer patients and their quality of life. In this study, the way in which the patients' network can effect their quality of life is examined. Two patient groups are distinguished: a group of cancer patients recently treated for their cancer by surgery and a group treated by chemotherapy (n=108 and n=109) and these are compared with a disease-free group of cancer patients (n=192). Although an association between network, social relations and quality of life is found, only a small part of the variation in quality of life can be explained by this social component. It seems that the cancer itself and the cancer treatment mainly affect the patients' quality of life and that the impact of the social environment is less significant.     

Self-reported quality of life in users and nonusers of dietary supplements in cancer

Goals of work To describe the Quality of Life (QoL) characteristics of users of dietary supplements vs nonusers.Patients and methods A survey of 225 cancer patients presenting for treatment at Cancer Treatment Centers of America was completed between November 2001 and October 2003. A validated instrument assessed the use of 56 dietary supplements in the past month. Two validated questionnaires assessed QoL. Mean QoL scores were compared between the users and nonusers using univariate and multivariate linear regression.Results Of 225 patients, 91 (40%) were males and 134 (60%) females. Sixty seven (30%) had breast cancer, 40 (18%) colorectal cancer, and 32 (14%) lung cancer. One hundred sixty four (73%) had used dietary supplements in the past month, while 61 (27%) had not. Mean European Organization for Research Treatment of Cancer QoL scores were significantly better among the users for physical and emotional function scales and fatigue, nausea, appetite loss, and constipation symptom scales adjusting for tumor site. In the stratified analysis, lung cancer patients did not show any statistically significant differences in QoL scores between the users and nonusers. Colorectal cancer patients demonstrated statistically significant differences in constipation symptom, with dietary supplement users having better QoL. Breast cancer patients demonstrated statistically significant differences in several QoL scale scores between users and nonusers.Conclusions Contrary to some of the previously published research, this study, conducted at a community hospital comprehensive cancer center that combines alternative treatment approaches with conventional cancer care, found better self-reported QoL among the users of dietary supplements, as compared to nonusers. The next step in this research is to prospectively evaluate the patterns of changing QoL in relation to dietary supplement use across the entire duration of cancer diagnosis and treatment.     

慢性阻塞性肺病患者肺功能和生活质量的研究

对５６例慢性阻塞性肺疾病患者进行肺通气功能测定和生活质量评估，结果显示反映气道阻塞程度的指标第１秒用力呼气容积占预计值百分比及第１秒用力呼气容积／用力肺活量与生活质量总均分的相关性均有统计学意义。     

The experience of fatigue, other symptoms and global quality of life during radiotherapy for uterine cancer

This paper reports on how patients with uterine cancer, receiving radiotherapy, experience fatigue, other symptoms and global quality of life. The results showed that fatigue increased significantly during the therapy. Also the other symptoms; loss of appetite, nausea/vomiting and diarrhoea increased significantly and were significantly correlated to general fatigue. Global quality of life decreased significantly during treatment compared to baseline. The variation of the level in general fatigue after completed therapy was only explained by the level of general fatigue experienced at baseline. The result can lead to a better understanding of the severity of symptoms experienced by patients with uterine cancer treated with radiotherapy.     

沙利度胺维持治疗对小细胞肺癌患者生存质量的影响

目的应用沙利度胺进行小细胞肺癌(SCLC)维持治疗,观察其对患者生存质量的影响。方法将完成规定周期化疗28例SCLC随机分为治疗组和对照组,每组各14例。治疗组应用沙利度胺100 mg/d,连续睡前顿服至少2个疗程(21 d为1个疗程);对照组定期复查随访。结果治疗组和对照组的功能状态Karnofsky评分改善率分别为71.43%和28.57%,两组比较差异无统计学意义(P=0.075);体重增加率为64.29%和28.57%,两组比较差异无统计学意义(P=0.058);两组治疗前后、治疗组治疗前后、对照组治疗前后生活质量(QOL)评分比较,差异均无统计学意义(P>0.05)。治疗组6例出现轻度不良反应,两组均未见严重药物不良反应。结论沙利度胺用于SCLC的维持治疗是安全的,对患者的生存质量无明显影响。     

Errors of measurement affecting the reliability and validity of data acquired from self-assessed quality of life

Research often uses self-assessed quality of life. Quality of life cannot be observed directly; other variables have to serve as its indicators. In the case of self-assessed quality of life, the researcher has to rely upon the individual's own statement as to how she/he feels. The subjective nature of the term creates problems in the matter of reliability and validity of the data thus collected. Random and systematic errors of measurement are liable to influence the result of the investigations. The researcher must know the possible sources of error and make allowances for them if research into quality of life is to be a worthwhile contribution to a greater understanding of what is meant by having a good life, and of the means to achieve it.     

心理干预对肺癌化疗患者生活质量的影响

目的探讨心理干预对肺癌化疗患者生活质量的影响,为临床护士更好的护理肺癌患者提供依据。方法将72例肺癌住院患者随机分为实验组和对照组,各36例,实验组全面准确评估生活质量后对患者实施认知一行为疗法、健康教育、音乐疗法3种方法相结合的心理干预,对照组只进行常规护理。采用欧洲癌症治疗研究组织研制的生活质量评定表（EORTC～C30）对实施心理干预前后2组患者的生活质量进行测评。结果实施心理干预后,实验组患者生活质量中部分功能如躯体功能、情绪功能等明显增强,部分化疗副反应如疲乏、恶心呕吐、失眠等得到改善,实验组与对照组生活质量比较有显著性差异（p〈0．05）。结论对肺癌化疗患者实施认知一行为疗法、健康教育和音乐疗法相结合的心理干预,能提高肺癌患者生活质量,且该方法简便、实用、经济,值得在临床护理实践中推广。     

Clinical validity of the Japanese version of the Functional Assessment of Cancer Therapy-Anemia Scale

Goals of work The purpose of this study was to reveal the clinical validity of the Japanese version of the Functional Assessment of Cancer Therapy-Anemia scale (FACT-An) in relation to hemoglobin level. We also analyzed patients’ scores for the related FACT-General scale (FACT-G), the FACT Anemia subscale, and the FACT Trial Outcome Index-Anemia scale (FACT TOI-An) to determine which was the most sensitive to anemia measurements. Materials and methods Throughout Japan, we recruited 227 patients (mean±SD, 59±12.1 years old) diagnosed with a variety of cancers. We correlated the severity of anemia, as measured by hemoglobin levels, to scores on the FACT-An and on the other scales at baseline and at 3 months. Main results The questionnaire completion rate was more than 98% at both time points. The FACT-An had high internal consistency (Cronbach’s alpha coefficient >0.8). FACT-An scores were significantly and positively correlated with hemoglobin levels both at baseline (r=0.24; 95% CI=0.12 to 0.36; n=225) and at 3 months (r=0.24; 95% CI=0.10 to 0.36; n=204). FACT-G, FACT Anemia subscale, and FACT TOI-An scores also successfully discriminated between patients with lower (Hb <11.0 g/dl) and higher (Hb ≥11.0 g/dl) hemoglobin levels. Moreover, the changes of these FACT scores over 3-months could discriminate changes in hemoglobin level. Conclusion The Japanese version of the FACT-An has higher clinical validity and can be used to appropriately assess health-related quality of life among Japanese cancer patients with anemia.     

社会支持与癌症患者生活质量的相关性研究及护理对策

目的:探讨社会支持与癌症患者生活质量的关系,寻求相应的护理对策.方法:调查60例癌症患者的社会支持情况,并与正常对照组进行比较;分析癌症患者的社会支持与其生活质量的相关性.结果:癌症患者的社会支持与正常对照组比较差异有统计学意义(P＜0.001);社会支持与其生活质量呈正性相关关系(r=0.617,P＜0.001).结论:癌症患者获得了比正常人高的社会支持;社会支持与癌症患者的生活质量密切相关;护理过程中重视社会支持可以改善护理效果、提高癌症患者的生活质量.