G Model LUNG-4540; No. of Pages 6
ARTICLE IN PRESS Lung Cancer xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
Lung Cancer journal homepage: www.elsevier.com/locate/lungcan
An investigation of symptom burden and quality of life in Chinese chemo-naïve advanced lung cancer patients by using the Instrument-Cloud QOL System Yuxiang Ma 1 , Yunpeng Yang 1 , Yan Huang 1 , Hongyun Zhao, Xue Hou, Ying Tian, Yuanyuan Zhao, Cong Xue, Wenfeng Fang, Xuan Wu, Zhihuang Hu, Wenhua Liang, Ting Zhou, Tao Qin, Li Zhang ∗ Sun Yat-Sen University Cancer Center, Department of Medical Oncology, Guangzhou, China
a r t i c l e
i n f o
Article history: Received 25 September 2013 Received in revised form 18 January 2014 Accepted 28 January 2014 Keywords: Quality of life Symptom burden Advanced lung cancer Cloud system FACT-L China
a b s t r a c t Objectives: This study was designed to assess the disease-related symptom burden and quality of life (QOL) in Chinese chemo-naïve advanced lung cancer patients. Materials and methods: Chemo-naïve patients with stage III/IV lung cancer were enrolled. 43 centers from 16 provinces of China participated in the study. Functional Assessment of Cancer Therapy-Lung (FACT-L) scale and Cloud QOL System were applied in the study. Results: 376 eligible patients were analyzed. The three most common and severe symptoms were appetite loss (84.3%, scored 2.46), breathing difficulty (79.0%, scored 2.56), and cough (75.5%, scored 2.81). Significant correlation was found between QOL and symptoms. Regression analysis of QOL indicated that almost every symptom item (except shortness of breath) was the negative indicator of QOL. Moreover, pulmonary diseases, pleural metastases and brain metastases had significant negative impact on both symptoms and QOL. Relatively poor performance status affected the QOL only, while cardiovascular diseases merely affected the symptoms. And patients with EGFR mutations had less symptom burden than those with wild-type EGFR. Conclusion: QOL evaluation by using the Cloud QOL System was feasible. Appetite loss, breathing difficulty and cough were the three most common and severe symptoms seen in Chinese chemo-naïve advanced lung cancer patients. Almost all symptoms had negative impact on QOL. And some clinical characteristics could predict the symptoms and QOL. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Patients with advanced lung cancer often experienced heavy symptoms such as pain, fatigue, cough, shortness of breath, loss of appetite and weight, which had profoundly negative impact on the quality of life (QOL) [1–3]. Several studies had shown significant relationship between overall survival and health-related QOL in cancer patients [4,5]. And a recent study indicated that symptom burden such as pain, dyspnea and loss of appetite could also predict the survival of advanced lung cancer patients [6]. Furthermore, the landmark study conducted by Temel and colleagues [7] had demonstrated that early palliative care could not only lead to
significant improvement in QOL, but also prolong the overall survival of metastatic non-small cell lung cancer patients (NSCLC). To manage the symptom appropriately and reduce its negative impact on QOL, it is essential to evaluate the symptom burden of patients with advanced lung cancer. There were several studies published recently to assess the symptom burden of lung cancer patients in the United States and Europe [8–10]. However, to our knowledge, there is still lacking similar studies in Chinese advanced lung cancer patients. Therefore, the current prospective multi-center study was aimed to evaluate the patient reported disease-related symptom burden, and its impact on health-related QOL in Chinese chemonaïve patients with advanced lung cancer. 2. Materials and methods
∗ Corresponding author at: Medical Oncology, Sun Yat-Sen University Cancer Center, 651# Dong Feng Road, East Guangzhou 510060, China. Tel.: +86 020 87343458; fax: +86 020 87343535. E-mail address: [email protected] (L. Zhang). 1 These authors contributed equally to this work.
2.1. Eligibility criteria Eligibility criteria of patients included histological confirmed lung cancer (including NSCLC and small cell lung cancer); advanced
0169-5002/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.lungcan.2014.01.027
Please cite this article in press as: Ma Y, et al. An investigation of symptom burden and quality of life in Chinese chemo-naïve advanced lung cancer patients by using the Instrument-Cloud QOL System. Lung Cancer (2014), http://dx.doi.org/10.1016/j.lungcan.2014.01.027
G Model LUNG-4540; No. of Pages 6
ARTICLE IN PRESS Y. Ma et al. / Lung Cancer xxx (2014) xxx–xxx
2
(stage III or IV) or recurrent disease (UICC classification version 7); no anti-cancer chemotherapy history. The protocol had been approved by the ethics committees of each participated hospitals, and all the participants had consented to QOL assessment before entering the study. Several studies had demonstrated that chemotherapy could impair the QOL of cancer patients. Therefore, in this study only chemo-naïve patients were enrolled to avoid the impact on QOL confounded by chemotherapy. 2.2. QOL assessment QOL was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale [11,12], which included four dimensions (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB and functional well-being, FWB) and Lung Cancer Subscale (LCS). Trial Outcome Index (TOI), which was the sum of physical well-being, functional well-being and LCS, was probably the most relevant and precise indicator of patient-reported QOL for lung cancer [13]. All QOL assessment was conducted before the anti-cancer treatment. 2.3. Symptom assessment The disease-related symptoms in lung cancer were quantified using seven items in LCS and two items in FACT-G, which were all included in FACT-Lung Symptom Index-12 (FLSI-12) [14,15]. The nine symptoms were shortness of breath, weight loss, unclear thinking, cough, appetite loss, tightness in chest, breathing difficulty, pain and lack of energy (supplementary Table 1). 3 items in FLSI-12 were excluded in the study: 2 (nausea and side effects of treatment) were considered treatment-related; the other (content with the QOL) was not a symptom. All the items were rated on a 5-point likert scale (the lower the score, the worse the symptom). The symptom assessment was also completed at baseline before the anti-cancer treatment. 2.4. Cloud QOL System In order to perform the study, a QOL analysis system based on cloud computing technology (Cloud QOL System) had been developed. The system consisted of two parts: the terminal equipment and the center cloud server, connected by wireless network (Fig. 1). The terminal equipment was a tablet PC (personal computer) using Android 2.3 operating system. Software for QOL evaluation with Chinese version of FACT-L questionnaire was developed and installed in the tablet PC. There were two principal functions of the software. Firstly, the tablet PC could automatically display the QOL questionnaires step by step through a simple and intuitive way (Fig. 2). Secondly, all of the patient’s answer data were automatically recorded, and could be uploaded to the center cloud server through Wi-Fi. The center cloud server could restore and analyze the data automatically. Whenever the tablet PC uploaded new data of a patient, the center cloud server would generate a summary histogram displaying every dimension of FACT-L. Furthermore, the center cloud server could compare the new data with the previous data of the same patient, and generated a diagram illustrating the variation trend of symptom burden and QOL individually in real time.
Fig. 1. The illustration of Cloud QOL System. The system consists of two parts: terminal equipment and center cloud server. Terminal equipment is responsible for data acquisition. Center cloud server connects every terminal equipment by Wi-Fi, and is responsible for data transmission, synchronization, analysis and sharing. An application is developed and installed in the tablet PC to collect data and present the result.
analyzed by Mann–Whitney U-test. Correlation was assessed by Pearson correlation analysis. A multivariate regression analysis was performed with FACT-TOI score as the dependent variable, and every symptom item as the predictor. All significance levels refer to two-sided tests. A P value of
ARTICLE IN PRESS Lung Cancer xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
Lung Cancer journal homepage: www.elsevier.com/locate/lungcan
An investigation of symptom burden and quality of life in Chinese chemo-naïve advanced lung cancer patients by using the Instrument-Cloud QOL System Yuxiang Ma 1 , Yunpeng Yang 1 , Yan Huang 1 , Hongyun Zhao, Xue Hou, Ying Tian, Yuanyuan Zhao, Cong Xue, Wenfeng Fang, Xuan Wu, Zhihuang Hu, Wenhua Liang, Ting Zhou, Tao Qin, Li Zhang ∗ Sun Yat-Sen University Cancer Center, Department of Medical Oncology, Guangzhou, China
a r t i c l e
i n f o
Article history: Received 25 September 2013 Received in revised form 18 January 2014 Accepted 28 January 2014 Keywords: Quality of life Symptom burden Advanced lung cancer Cloud system FACT-L China
a b s t r a c t Objectives: This study was designed to assess the disease-related symptom burden and quality of life (QOL) in Chinese chemo-naïve advanced lung cancer patients. Materials and methods: Chemo-naïve patients with stage III/IV lung cancer were enrolled. 43 centers from 16 provinces of China participated in the study. Functional Assessment of Cancer Therapy-Lung (FACT-L) scale and Cloud QOL System were applied in the study. Results: 376 eligible patients were analyzed. The three most common and severe symptoms were appetite loss (84.3%, scored 2.46), breathing difficulty (79.0%, scored 2.56), and cough (75.5%, scored 2.81). Significant correlation was found between QOL and symptoms. Regression analysis of QOL indicated that almost every symptom item (except shortness of breath) was the negative indicator of QOL. Moreover, pulmonary diseases, pleural metastases and brain metastases had significant negative impact on both symptoms and QOL. Relatively poor performance status affected the QOL only, while cardiovascular diseases merely affected the symptoms. And patients with EGFR mutations had less symptom burden than those with wild-type EGFR. Conclusion: QOL evaluation by using the Cloud QOL System was feasible. Appetite loss, breathing difficulty and cough were the three most common and severe symptoms seen in Chinese chemo-naïve advanced lung cancer patients. Almost all symptoms had negative impact on QOL. And some clinical characteristics could predict the symptoms and QOL. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction Patients with advanced lung cancer often experienced heavy symptoms such as pain, fatigue, cough, shortness of breath, loss of appetite and weight, which had profoundly negative impact on the quality of life (QOL) [1–3]. Several studies had shown significant relationship between overall survival and health-related QOL in cancer patients [4,5]. And a recent study indicated that symptom burden such as pain, dyspnea and loss of appetite could also predict the survival of advanced lung cancer patients [6]. Furthermore, the landmark study conducted by Temel and colleagues [7] had demonstrated that early palliative care could not only lead to
significant improvement in QOL, but also prolong the overall survival of metastatic non-small cell lung cancer patients (NSCLC). To manage the symptom appropriately and reduce its negative impact on QOL, it is essential to evaluate the symptom burden of patients with advanced lung cancer. There were several studies published recently to assess the symptom burden of lung cancer patients in the United States and Europe [8–10]. However, to our knowledge, there is still lacking similar studies in Chinese advanced lung cancer patients. Therefore, the current prospective multi-center study was aimed to evaluate the patient reported disease-related symptom burden, and its impact on health-related QOL in Chinese chemonaïve patients with advanced lung cancer. 2. Materials and methods
∗ Corresponding author at: Medical Oncology, Sun Yat-Sen University Cancer Center, 651# Dong Feng Road, East Guangzhou 510060, China. Tel.: +86 020 87343458; fax: +86 020 87343535. E-mail address: [email protected] (L. Zhang). 1 These authors contributed equally to this work.
2.1. Eligibility criteria Eligibility criteria of patients included histological confirmed lung cancer (including NSCLC and small cell lung cancer); advanced
0169-5002/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.lungcan.2014.01.027
Please cite this article in press as: Ma Y, et al. An investigation of symptom burden and quality of life in Chinese chemo-naïve advanced lung cancer patients by using the Instrument-Cloud QOL System. Lung Cancer (2014), http://dx.doi.org/10.1016/j.lungcan.2014.01.027
G Model LUNG-4540; No. of Pages 6
ARTICLE IN PRESS Y. Ma et al. / Lung Cancer xxx (2014) xxx–xxx
2
(stage III or IV) or recurrent disease (UICC classification version 7); no anti-cancer chemotherapy history. The protocol had been approved by the ethics committees of each participated hospitals, and all the participants had consented to QOL assessment before entering the study. Several studies had demonstrated that chemotherapy could impair the QOL of cancer patients. Therefore, in this study only chemo-naïve patients were enrolled to avoid the impact on QOL confounded by chemotherapy. 2.2. QOL assessment QOL was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale [11,12], which included four dimensions (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB and functional well-being, FWB) and Lung Cancer Subscale (LCS). Trial Outcome Index (TOI), which was the sum of physical well-being, functional well-being and LCS, was probably the most relevant and precise indicator of patient-reported QOL for lung cancer [13]. All QOL assessment was conducted before the anti-cancer treatment. 2.3. Symptom assessment The disease-related symptoms in lung cancer were quantified using seven items in LCS and two items in FACT-G, which were all included in FACT-Lung Symptom Index-12 (FLSI-12) [14,15]. The nine symptoms were shortness of breath, weight loss, unclear thinking, cough, appetite loss, tightness in chest, breathing difficulty, pain and lack of energy (supplementary Table 1). 3 items in FLSI-12 were excluded in the study: 2 (nausea and side effects of treatment) were considered treatment-related; the other (content with the QOL) was not a symptom. All the items were rated on a 5-point likert scale (the lower the score, the worse the symptom). The symptom assessment was also completed at baseline before the anti-cancer treatment. 2.4. Cloud QOL System In order to perform the study, a QOL analysis system based on cloud computing technology (Cloud QOL System) had been developed. The system consisted of two parts: the terminal equipment and the center cloud server, connected by wireless network (Fig. 1). The terminal equipment was a tablet PC (personal computer) using Android 2.3 operating system. Software for QOL evaluation with Chinese version of FACT-L questionnaire was developed and installed in the tablet PC. There were two principal functions of the software. Firstly, the tablet PC could automatically display the QOL questionnaires step by step through a simple and intuitive way (Fig. 2). Secondly, all of the patient’s answer data were automatically recorded, and could be uploaded to the center cloud server through Wi-Fi. The center cloud server could restore and analyze the data automatically. Whenever the tablet PC uploaded new data of a patient, the center cloud server would generate a summary histogram displaying every dimension of FACT-L. Furthermore, the center cloud server could compare the new data with the previous data of the same patient, and generated a diagram illustrating the variation trend of symptom burden and QOL individually in real time.
Fig. 1. The illustration of Cloud QOL System. The system consists of two parts: terminal equipment and center cloud server. Terminal equipment is responsible for data acquisition. Center cloud server connects every terminal equipment by Wi-Fi, and is responsible for data transmission, synchronization, analysis and sharing. An application is developed and installed in the tablet PC to collect data and present the result.
analyzed by Mann–Whitney U-test. Correlation was assessed by Pearson correlation analysis. A multivariate regression analysis was performed with FACT-TOI score as the dependent variable, and every symptom item as the predictor. All significance levels refer to two-sided tests. A P value of
