Research
Changes in symptom severity in Taiwanese lung cancer patients after gefitinib treatment: a pilot study Shu-Yi Wang, Chun-Ming Tsai, Chia-Chin Lin
© 2014 MA Healthcare Ltd
L
ung cancer has the second highest yearly mortality rate among all cancers in Taiwan (Taiwan Cancer Registry, 2008). Metastasis leads to a poor prognosis and a lower overall 5-year survival rate (Chan et al, 2011). Recent developments have enabled genetically targeted therapies to be used to manage the symptoms of lung cancer and lengthen a patient’s life (Paez et al, 2004), but such therapies may also have severe side effects that compromise the patient’s quality of life (QoL) (Cappuzzo et al, 2004). The drug most commonly used to treat lung cancer in Taiwan is gefitinib. At the daily dose of 250 mg, patients with advanced lung cancer are vulnerable to multiple physical symptoms during and after treatment, including diarrhoea, dry mouth, skin rashes, and acute interstitial pneumonia (Mehta et al, 2013), which can greatly affect their functioning. However, symptom improvement has been observed in 35% of patients after 1 month of gefitinib therapy (Cappuzzo et al, 2004) and one study reported a median duration of gefitinib treatment of 183 days (Mehta et al, 2013). Cancer symptoms are multidimensional: they vary in frequency, intensity, and severity, change over time, and appear to have a relation to survival. Symptoms are inherently important, not only because they can have considerable impact on a patient’s QoL, but also because they may indicate the presence of a concomitant condition (Cheville et al, 2011a). There is growing interest in the idea that a more encompassing consideration of symptoms may provide benefits in the form of improved prognostication, screening, and treatment optimisation (Cheville et al, 2011b). Results from previous studies identified several symptoms associated with poor patient performance. Although there are an increasing number of studies on symptom management in cancer patients, many studies are cross-sectional and limited to patients actively undergoing treatment (Xiao, 2010). Toxicities of targeted therapy may contribute to a patient’s general symptom severity during the course of treatment. Reducing the burden of
International Journal of Palliative Nursing 2014, Vol 20, No 3
Abstract
Aim: The purpose of this study was to investigate symptom severity in advanced non-small cell lung cancer patients prior to gefitinib treatment and at 1-, 3- and 6-month intervals after starting treatment. Methodology: Fifty seven patients completed the Taiwanese version of the M.D. Anderson Symptom Inventory. The data were analysed using descriptive statistics, the Friedman non-parametric test, and Pearson correlation coefficients. Results: Symptoms of nausea, difficulty remembering, lack of appetite, sadness, and vomiting increased at 1 month after treatment started, pain and shortness of breath increased at 3 months, and disturbed sleep, drowsiness, and numbness increased after 6 months. Fatigue and dry mouth increased at 3 months after treatment started and then decreased. Only distress decreased throughout the course of treatment. Conclusion: The findings may lead to the development of better clinical guidelines and improved information for patients on when to expect the greatest impact from their symptoms during the course of treatment. Key words: Symptom severity l Symptom interference l Non-small cell lung cancer l Gefitinib treatment l Targeted therapy
treatment-related symptoms on a patient’s functional status should be an important treatment goal, especially during aggressive curative therapy. Results of longitudinal studies indicate avenues for more accurate methods of patient monitoring that might lead to the development of better clinical guidelines and provide better information for patients about when to expect the greatest impact from their symptoms (Xiao, 2010). Based on this consideration and estimation of the change in symptom severity throughout the course of gefitinib treatment, the present study aimed to investigate levels of symptom severity in patients with advanced non-small cell lung cancer (NSCLC) prior to treatment and at 1-, 3-, and 6-month intervals after starting gefitinib treatment.
Methods
Sample and setting
Eligible participants were required to be mentally competent, to be able to communicate in
Shu-Yi Wang is Associate Professor, Regis University, Colorado, USA; Chun-Ming Tsai is Medical Doctor, Chest Department, Taipei Veterans’ General Hospital and School of Medicine, National Yang-Ming University, Taipei, Taiwan; Chia-Chin Lin is Professor and Dean, College of Nursing, Taipei Medical University, Taipei, Taiwan Correspondence to: Chia-Chin Lin [email protected]
135
onal Journal of Palliative Nursing. Downloaded from magonlinelibrary.com by 130.194.020.173 on November 21, 2015. For personal use only. No other uses without permission. . All rights r
Research
Mandarin or Taiwanese, to have been diagnosed with NSCLC within the previous year, to have received a daily dose of gefitinib treatment, and to be 18 years of age or older. Participants were recruited by convenience sampling from among thoracic oncology inpatients and outpatients at a medical centre in northern Taiwan between September 2005 and July 2007. Fifty seven patients with NSCLC were included. Patients who could not understand the content of the study instrument, who refused to complete the instrument throughout the course of treatment, or who stopped the gefitinib treatment, were excluded from the study.
Instruments Demographic and medical characteristics Demographic and medical information was obtained from each patient’s chart and through a face-to-face interview. Taiwanese version of the M.D. Anderson Symptom Inventory (MDASI-T) The study used the Taiwanese version of the M.D. Anderson Symptom Inventory (MDASI-T). The MDASI, developed by Cleeland et al (2000), is a multidimensional assessment form with 19 evaluation items designed to evaluate cancer patients’ symptom severity using a 0 to 10 numerical rating scale. There are 13 core symptom severity items, relating to fatigue, sleep disturbance, pain, drowsiness, poor appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, dry mouth, distress, and sadness. In addition, there are six items relating to interference with activities of daily living (ADLs): general activity, mood, work, relations with other people, walking, and enjoyment of life. The scale is completed by the patients themselves, with 0 representing ‘no symptom’ and 10 representing a severity that is ‘the worst you can ever imagine’; 1–4 points indicate a mild level of symptom severity, 5–6 points indicate a medium level of symptom severity, and 7 or more points indicate serious symptom severity. A symptom severity composite (total) score is computed from the mean of the 13 individual symptom item scores and an interference composite (total) score is computed from the mean of the six individual ADL item scores. The underlying constructs include a general symptom severity factor and a gastrointestinal symptom severity factor. The MDASI can be completed with minimal effort regardless of diagnosis or type of therapy (Cleeland et al, 2000), and hence it is well suited for a longitudinal study when repeated measures are required. The internal consistencies of the
136
symptom severity and symptom interference items have been found to have Cronbach-a scores of 0.82–0.94 (Cleeland et al, 2000). The MDASI-T has been widely used in studies involving cancer patients in Taiwan, and reliability and validity have been well established (Lin et al, 2007). The internal consistency Cronbach-a was 0.89 for the symptom severity items and 0.94 for the symptom interference items (Lin et al, 2007). Karnofsky Performance Scale Scores obtained with the Karnofsky Performance Scale (KPS) are strong predictors of patient QoL (Buccheri et al, 1996). The KPS gives a rating from 0 (dead) to 100 (normal). Scores ≤40 indicate dependency, scores in the range 50–60 indicate the need for assistance, and scores ≥70 indicate ability to provide self-care.
Ethical considerations Ethical approval for the study was obtained from the Human Subject Committee of Taipei Medical University. Patients were informed that their participation was voluntary, anonymous and confidential, and that they could withdraw from the study at any time without penalty.
Data collection A research assistant recruited patients and provided a face-to face explanation of the study. During the interview process, the research assistant explained how to fill out the questionnaire. Patients were asked to fill in demographic and medical characteristic information and completed the MDASI-T in about 10 minutes. If a patient was unable to fill out the questionnaire by him/herself, because of factors including blurred vision or being illiterate, the research assistant read the questions and recorded the answers. Data collection procedures were repeated at 1, 3, and 6 months after baseline at each physician’s visit.
Statistical analysis The data were encoded and statistically analysed using SPSS 15.0 (SPSS Inc., Chicago, IL, USA). Descriptive statistics including the mean (M) and standard deviation (SD) were used to summarise demographic and medical characteristic variables. The Friedman non-parametric test and two-way analysis of variance were used to examine changes in symptom severity across time. Symptom severity during the course of treatment was represented by the mean highest intensity of each symptom reported by patients. Associations among variables were examined by Pearson
© 2014 MA Healthcare Ltd
❛Cancer symptoms are multidimensional: they vary in frequency, intensity, and severity, change over time, and appear to have a relation to survival.❜
International Journal of Palliative Nursing 2014, Vol 20, No 3
onal Journal of Palliative Nursing. Downloaded from magonlinelibrary.com by 130.194.020.173 on November 21, 2015. For personal use only. No other uses without permission. . All rights r
Research
correlation coefficients. The level of statistical significance was set at P
Changes in symptom severity in Taiwanese lung cancer patients after gefitinib treatment: a pilot study Shu-Yi Wang, Chun-Ming Tsai, Chia-Chin Lin
© 2014 MA Healthcare Ltd
L
ung cancer has the second highest yearly mortality rate among all cancers in Taiwan (Taiwan Cancer Registry, 2008). Metastasis leads to a poor prognosis and a lower overall 5-year survival rate (Chan et al, 2011). Recent developments have enabled genetically targeted therapies to be used to manage the symptoms of lung cancer and lengthen a patient’s life (Paez et al, 2004), but such therapies may also have severe side effects that compromise the patient’s quality of life (QoL) (Cappuzzo et al, 2004). The drug most commonly used to treat lung cancer in Taiwan is gefitinib. At the daily dose of 250 mg, patients with advanced lung cancer are vulnerable to multiple physical symptoms during and after treatment, including diarrhoea, dry mouth, skin rashes, and acute interstitial pneumonia (Mehta et al, 2013), which can greatly affect their functioning. However, symptom improvement has been observed in 35% of patients after 1 month of gefitinib therapy (Cappuzzo et al, 2004) and one study reported a median duration of gefitinib treatment of 183 days (Mehta et al, 2013). Cancer symptoms are multidimensional: they vary in frequency, intensity, and severity, change over time, and appear to have a relation to survival. Symptoms are inherently important, not only because they can have considerable impact on a patient’s QoL, but also because they may indicate the presence of a concomitant condition (Cheville et al, 2011a). There is growing interest in the idea that a more encompassing consideration of symptoms may provide benefits in the form of improved prognostication, screening, and treatment optimisation (Cheville et al, 2011b). Results from previous studies identified several symptoms associated with poor patient performance. Although there are an increasing number of studies on symptom management in cancer patients, many studies are cross-sectional and limited to patients actively undergoing treatment (Xiao, 2010). Toxicities of targeted therapy may contribute to a patient’s general symptom severity during the course of treatment. Reducing the burden of
International Journal of Palliative Nursing 2014, Vol 20, No 3
Abstract
Aim: The purpose of this study was to investigate symptom severity in advanced non-small cell lung cancer patients prior to gefitinib treatment and at 1-, 3- and 6-month intervals after starting treatment. Methodology: Fifty seven patients completed the Taiwanese version of the M.D. Anderson Symptom Inventory. The data were analysed using descriptive statistics, the Friedman non-parametric test, and Pearson correlation coefficients. Results: Symptoms of nausea, difficulty remembering, lack of appetite, sadness, and vomiting increased at 1 month after treatment started, pain and shortness of breath increased at 3 months, and disturbed sleep, drowsiness, and numbness increased after 6 months. Fatigue and dry mouth increased at 3 months after treatment started and then decreased. Only distress decreased throughout the course of treatment. Conclusion: The findings may lead to the development of better clinical guidelines and improved information for patients on when to expect the greatest impact from their symptoms during the course of treatment. Key words: Symptom severity l Symptom interference l Non-small cell lung cancer l Gefitinib treatment l Targeted therapy
treatment-related symptoms on a patient’s functional status should be an important treatment goal, especially during aggressive curative therapy. Results of longitudinal studies indicate avenues for more accurate methods of patient monitoring that might lead to the development of better clinical guidelines and provide better information for patients about when to expect the greatest impact from their symptoms (Xiao, 2010). Based on this consideration and estimation of the change in symptom severity throughout the course of gefitinib treatment, the present study aimed to investigate levels of symptom severity in patients with advanced non-small cell lung cancer (NSCLC) prior to treatment and at 1-, 3-, and 6-month intervals after starting gefitinib treatment.
Methods
Sample and setting
Eligible participants were required to be mentally competent, to be able to communicate in
Shu-Yi Wang is Associate Professor, Regis University, Colorado, USA; Chun-Ming Tsai is Medical Doctor, Chest Department, Taipei Veterans’ General Hospital and School of Medicine, National Yang-Ming University, Taipei, Taiwan; Chia-Chin Lin is Professor and Dean, College of Nursing, Taipei Medical University, Taipei, Taiwan Correspondence to: Chia-Chin Lin [email protected]
135
onal Journal of Palliative Nursing. Downloaded from magonlinelibrary.com by 130.194.020.173 on November 21, 2015. For personal use only. No other uses without permission. . All rights r
Research
Mandarin or Taiwanese, to have been diagnosed with NSCLC within the previous year, to have received a daily dose of gefitinib treatment, and to be 18 years of age or older. Participants were recruited by convenience sampling from among thoracic oncology inpatients and outpatients at a medical centre in northern Taiwan between September 2005 and July 2007. Fifty seven patients with NSCLC were included. Patients who could not understand the content of the study instrument, who refused to complete the instrument throughout the course of treatment, or who stopped the gefitinib treatment, were excluded from the study.
Instruments Demographic and medical characteristics Demographic and medical information was obtained from each patient’s chart and through a face-to-face interview. Taiwanese version of the M.D. Anderson Symptom Inventory (MDASI-T) The study used the Taiwanese version of the M.D. Anderson Symptom Inventory (MDASI-T). The MDASI, developed by Cleeland et al (2000), is a multidimensional assessment form with 19 evaluation items designed to evaluate cancer patients’ symptom severity using a 0 to 10 numerical rating scale. There are 13 core symptom severity items, relating to fatigue, sleep disturbance, pain, drowsiness, poor appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, dry mouth, distress, and sadness. In addition, there are six items relating to interference with activities of daily living (ADLs): general activity, mood, work, relations with other people, walking, and enjoyment of life. The scale is completed by the patients themselves, with 0 representing ‘no symptom’ and 10 representing a severity that is ‘the worst you can ever imagine’; 1–4 points indicate a mild level of symptom severity, 5–6 points indicate a medium level of symptom severity, and 7 or more points indicate serious symptom severity. A symptom severity composite (total) score is computed from the mean of the 13 individual symptom item scores and an interference composite (total) score is computed from the mean of the six individual ADL item scores. The underlying constructs include a general symptom severity factor and a gastrointestinal symptom severity factor. The MDASI can be completed with minimal effort regardless of diagnosis or type of therapy (Cleeland et al, 2000), and hence it is well suited for a longitudinal study when repeated measures are required. The internal consistencies of the
136
symptom severity and symptom interference items have been found to have Cronbach-a scores of 0.82–0.94 (Cleeland et al, 2000). The MDASI-T has been widely used in studies involving cancer patients in Taiwan, and reliability and validity have been well established (Lin et al, 2007). The internal consistency Cronbach-a was 0.89 for the symptom severity items and 0.94 for the symptom interference items (Lin et al, 2007). Karnofsky Performance Scale Scores obtained with the Karnofsky Performance Scale (KPS) are strong predictors of patient QoL (Buccheri et al, 1996). The KPS gives a rating from 0 (dead) to 100 (normal). Scores ≤40 indicate dependency, scores in the range 50–60 indicate the need for assistance, and scores ≥70 indicate ability to provide self-care.
Ethical considerations Ethical approval for the study was obtained from the Human Subject Committee of Taipei Medical University. Patients were informed that their participation was voluntary, anonymous and confidential, and that they could withdraw from the study at any time without penalty.
Data collection A research assistant recruited patients and provided a face-to face explanation of the study. During the interview process, the research assistant explained how to fill out the questionnaire. Patients were asked to fill in demographic and medical characteristic information and completed the MDASI-T in about 10 minutes. If a patient was unable to fill out the questionnaire by him/herself, because of factors including blurred vision or being illiterate, the research assistant read the questions and recorded the answers. Data collection procedures were repeated at 1, 3, and 6 months after baseline at each physician’s visit.
Statistical analysis The data were encoded and statistically analysed using SPSS 15.0 (SPSS Inc., Chicago, IL, USA). Descriptive statistics including the mean (M) and standard deviation (SD) were used to summarise demographic and medical characteristic variables. The Friedman non-parametric test and two-way analysis of variance were used to examine changes in symptom severity across time. Symptom severity during the course of treatment was represented by the mean highest intensity of each symptom reported by patients. Associations among variables were examined by Pearson
© 2014 MA Healthcare Ltd
❛Cancer symptoms are multidimensional: they vary in frequency, intensity, and severity, change over time, and appear to have a relation to survival.❜
International Journal of Palliative Nursing 2014, Vol 20, No 3
onal Journal of Palliative Nursing. Downloaded from magonlinelibrary.com by 130.194.020.173 on November 21, 2015. For personal use only. No other uses without permission. . All rights r
Research
correlation coefficients. The level of statistical significance was set at P
