| BACKGROUDThe World Health Organization (WHO) indicates that cancer is the second leading killer after cardiovascular disease. It is difficult to cure cancer and to improve survival time, so we can not use cure rate and survival rate to evaluate the therapeutic effect. As the medical model is transforming from biological model to biological-psychological-social model, the purpose of medical science is to relief pain and to improve quality of life. Cancer patients experience a variety of symptoms due to disease or treatment during disease trajectory. These symptoms affect the patients’functional status, quality of life and treatment effect directly or indirectly. Therefore, symptom management is an important part in cancer treatment.Lung cancer is the most common malignant tumor in China. It is also the first cause of cancer deaths, accounting for22.7%of all cancer deaths, and the morbidity and mortality continues to rise. According to Ministry of Health statistics, the morbidity of lung cancer increases of26.9%each year. If we do not take effective measures, lung cancer patients will reach100million by2025. China will be the first lung cancer power. Patients with lung cancer burden more severe symptoms compared to other cancer patients.Symptom management in lung cancer patients has important practical significance. Assessment tool is crucial for symptom management. M. D. Anderson Symptom Inventory (MDASI) is often used in cancer symptom assessment. It is developed by the University of Texas M. D. Anderson Cancer Center. The center has also developed several specific modules for different cancers, such as brain cancer module, head and neck cancer module, thyroid cancer module, lung cancer module. The lung cancer module consists of three symptoms, which are cough, constipation and sore throat. There are no reports about whether the lung cancer module is suitable for the status of domestic lung cancer patients and whether it results in deviation in symptom evaluation and whether it impacts the symptom management. In order to manage the symptoms accurately and efficiently, the study is proposed to confirm the symptom clusters and influencing factors of lung cancer patients on basis of revising the lung cancer module.OBJECTIVE1. According to MDASI, revise the existing lung cancer module, develop a symptom assessment tool suitable for domestic lung cancer patients, provide an assessment tool for symptom cluster study on lung cancer patients.2. Chinese version of M. D. Anderson Symptom Assessment Scale (MDASI-C) and revised lung cancer module are used to assess the symptoms of lung cancer patients in order to confirm the symptom clusters and influencing factors.METHODSFirst, determine the dimensions of common symptoms of lung cancer patients. Second, develop lung cancer symptom item pool on basis of literature review, clinical investigation, expert interview and cancer symptom assessment tools. Experts select the appropriate symptoms from item pool. Expert inclusion criteria:medical experts and nursing experts on lung cancer, with senior professional title, with bachelor degree or above, working on lung cancer more than10years, be willingness to participate in this study. There are two rounds in this expert evaluation. The first round consists of10experts. The second round consists of6experts. Two evaluations interval of14days.After a small range of pre-trial, modify the questionnaire (including demographic information and treatment information, MDASI-C, revised lung cancer module, SF-12quality of life scale). Using convenience sampling method, investigate264lung cancer patients in3hospitals of Guangzhou. Evaluate the feasibility, reliability, validity and sensitivity of the revised lung cancer module according to the data.Using convenience sampling method, investigate214lung cancer patients in3hospitals of Guangzhou with MDASI-C and revised lung cancer module. Explore symptom clusters and its influencing factors.All data was entry and analyzed by using statistical package SPSS13.0software. Statistical methods:descriptive statistics, Mann-Whitney rank sum test, Spearman correlation analysis, Cronbach’s a coefficient, content validity index (CVI), exploratory factor analysis, Kruskal-wallis H test, multiple regression analysis. The inspection level a=0.05.RESULTS1. Common symptom item pool of lung cancer patientsBased on literature review, clinical investigation, expert interview and cancer symptom assessment tools, determined the whole symptoms of four dimensions. There were9items in general symptoms of primary lung tumor,19items in cancer metastasis symptoms,18items in treatment-related symptoms,6items in common psychological symptoms. Some symptoms belonged to one dimension, some symptoms belonged to several dimensions. The item pool included a total of32 symptoms, such as pain, fatigue, shortness of breath, cough, expectoration and so on.2. Revised lung cancer module10experts participated in the first round expert evaluation, retaining14symptoms of which CVI≥0.8and sore throat symptom.6experts participated in the second round expert evaluation, retaining13symptoms of which CVI≥0.8, deleting7symptoms the same with MDASI-C. The remaining6symptoms consisted of the revised lung cancer module, which were cough, expectoration, hemoptysis, chest tightness, constipation, weight loss.3. Scale evaluationA total of300questionnaires were distributed,285questionnaires recycled,264valid questionnaires. Recovery was95.0%and efficiency was88.0%. The completion time was10to15minutes, the revised lung cancer module had good feasibility. The Cronbach’s a coefficient of revised lung cancer module was0.763, the Cronbach’s a coefficient of revised lung cancer module and MDASI-C was0.925, internal consistency reliability was good. The item-level CVI (item-level CVI, I-CVI) was0.833to1.000, the scale-level CVI (S-CVI/Ave) was0.944, the content validity was high. Exploratory factor analysis obtained two factors. The cumulative variance contribution rate was63.933%. The factor loadings were greater than0.40. The result of factor analysis was consistent with the theoretical framework of lung cancer symptoms. The construct validity was good. The spearman coefficient between lung cancer module score and SF-12total score was-0.439. The spearman coefficients between lung cancer module score and SF-12demension score were-0.209～-0.408. All of them had statistical significance. Criterion validity was good. Lung cancer module scores between patients with different ECOG performance status had significantly difference. The sensitivity was good.4. Symptom clusters of lung cancer patients A total of250questionnaires were distributed,235questionnaires recycled,214valid questionnaires. Recovery was94.0%and efficiency was85.6%. There were five symptom clusters in lung cancer patients through exploratory factor analysis, which were disease-behavioral symptom cluster, lung cancer specific symptom cluster, gastrointestinal symptom cluster, respiratory symptom cluster, disturbed sleep-drymouth symptom cluster. Total variance contribution rate was56.930%. Disease-behavioral symptom cluster included pain, fatigue, upset, sad and drowsy, its variance contribution rate was28.500%. Lung cancer specific symptom cluster included cough, expectoration and hemoptysis, its variance contribution rate was9.384%. Gastrointestinal symptom cluster included nausea, vomiting and lack of appetite, its variance contribution rate was7.154%. Respiratory symptom cluster included chest tightness, shortness of breath and rememberless, its variance contribution rate was6.184%. Disturbed sleep-drymouth symptom cluster included disturbed sleep and dry mouth, its variance contribution rate was5.709%. The Cronbach’s a coefficients of symptom clusters were0.771,0.730,0.736,0.626,0.484.5. Influencing factors of symptom clustersBy multiple regression analysis, the influencing factor of disease-behavioral symptom cluster was ECOG performance status. The influencing factors of lung cancer specific symptom cluster were ECOG performance status, gender and cancer stage. The influencing factors of gastrointestinal symptom cluster were ECOG performance status, age, concomitant diseases and undergoing treatment. The influencing factor of respiratory symptom cluster was ECOG performance status. The influencing factor of disturbed sleep-drymouth symptom cluster was ECOG performance status.CONCLUSIONS1. Establish revised lung cancer module for lung cancer patients in China With method of expert evaluation, medical experts and nursing experts are invited to participate in two rounds evaluations for lung cancer symptom item pool. Ultimately determine the revised lung cancer module with good feasibility, reliability, validity and sensitivity. We provides a good assessment tool for symptom management of domestic patients with lung cancer.2. Confirm symptom clusters and influencing factors of lung cancer patientsPatients with lung cancer have varieties of symptoms in disease trajectory. The most severe symptoms are disturbed sleep, fatigue, pain, constipation, which result in severe distress to the patients’ daily life. Lung cancer patients have five symptom clusters, which are disease-behavioral symptom cluster, lung cancer specific symptom cluster, gastrointestinal symptom cluster, respiratory symptom cluster, disturbed sleep-drymouth symptom cluster. The influencing factors of symptom clusters are ECOG performance status, age, sex, cancer stage, concomitant diseases, and undergoing treatment. Symptom management targeting for symptom cluster has more advantages than individual symptoms. Symptom cluster is a trend in the field of cancer symptom management. |
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