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75 A Risk Prediction Model of Chemotherapy Related Nausea and Vomiting
Poster Presentations / European Journal of Oncology Nursing 16S1 (2012) S21–S46
73 Nursing Management of Patients Taking Everolimus – an Oral MTor Inhibitor L. Lemmens1 , J. Van Steijn2 , A. Wojtasik3 . 1 University Hospitals Leuven, Digestive Oncology, Leuven, Belgium; 2 Leids Universitair Medisch Centrum, Klinische Oncologie, Leiden, The Netherlands; 3 GZA Ziekenhuizen Campus Sint-Augustinus, Oncologie, Wilrijk, Belgium Everolimus (Afinitor) is a novel oral targeted therapy that is approved for the treatment of advanced renal cell carcinoma and advanced progressive neuroendocrine tumours of pancreatic origin. A recent study has shown that everolimus in combination with exemestane increases progression free survival, in comparison to exemestane alone, when used in postmenopausal women with ER+HER2− advanced breast cancer, however, everolimus has not yet been approved for this indication. Everolimus is administered once per day. Like all targeted therapies everolimus can cause a number of burdensome side effects that can have a negative impact on patients’ quality of life. Common side effects include stomatitis, fatigue, anaemia, neutropenia (and related infections), thrombocytopenia, diarrhoea, non-infectious pneumonitis, oedema and metabolic disturbances (including hyperglycaemia, hypercholesterolaemia and hypertriglyceridaemia). Whilst some of these side effects overlap with those seen with other cancer drugs, a number are unique to mTOR inhibitors. For example, the aphtous ulceration associated with everolimus is different to the mucositis seen with conventional cytotoxics and non-infectious pneumonitis is a class effect of mTOR inhibitors. Non-infectious pneumonitis is a potentially life-threatening side effect of everolimus that requires close monitoring and prompt intervention. Like many oral targeted therapies everolimus is a substrate of CYP3A4 and there is a risk of interaction when it is taken concomitantly with CYP3A4 inducers and inhibitors (drugs or food). This presentation aims to increase nurses’ knowledge about how to prevent, detect early and effectively manage everolimus-related side effects. Particular emphasis will be placed on how to manage the more unique side effects associated with everolimus such as apthous ulceration, metabolic disturbances and non-infectious pneumonitis. The presentation will also highlight the risk of drug interaction when everolimus is used concomitantly with strong CYP34 inducers/inhibitors where there is a need to consider dose adjustments. In addition, it will be emphasised that everolimus is a continuous, long-term treatment and therefore some patients may struggle with adherence, especially if they have to take other oral medicines. Interventions targeted at promoting medicines adherence such as the provision of tailored patient education, effective side effect management and on-going support will be reviewed. Finally, the presentation will point to the importance of managing everolimus-related side effects within the context of a multidisciplinary team. 74 Comparison of Fatigue of Patients With Cancer and Their Family Caregivers 1 1 ¨ ¨ Usta Yesilbalkan1 , F. Ozdemir . Ege University Faculty of Nursing, O. Izmir, Turkey
Objectives: The purpose of this study was to compare the fatigue of cancer patients and their family caregivers. Methods: A total of 90 paired patients and family caregivers from an outpatient chemotherapy unit of the oncology units were recruited. Both patients and their caregivers completed Fatigue Severity Scale. Independent t-tests were used to test whether a statistically significant difference in the fatigue scores for patients and family caregivers.
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Results: The mean age of patients was 51.01 years, and of their family caregivers was 46.38. The results indicated that the patients had higher fatigue scores than their family caregivers. Conclusions: Family caregivers need to be assessed, along with patients, for fatigue, and appropriate interventions initiated for them and for the patient. 75 A Risk Prediction Model of Chemotherapy Related Nausea and Vomiting Z. Stamataki1 , A. Molassiotis1 , E. Kontopantelis2 . 1 University of Manchester, School of Nursing Midwifery and Social Work, Manchester, United Kingdom; 2 University of Manchester, Health Sciences Primary Care Research Group, Manchester, United Kingdom Introduction: While the management of chemotherapy-induced vomiting has improved over the years, with the variation of antiemetic regimens, nausea still remains a significant clinical problem. The study is looking to (a) assess the contribution of clinical, physiological and psychological variables in the development of chemotherapy-related nausea and vomiting, and (b) develop and validate a risk prediction model for CINV. Material and Methods: This is a two phase-prospective, observational, longitudinal study over 3 cycles of chemotherapy. Phase 1: At baseline, patients completed the State-Trait Anxiety Inventory, Symptom Distress Scale and a descriptive questionnaire with their socio-demographics, history of nausea/vomiting and expectation of nausea. At each cycle, patients completed the MASCC Antiemesis Tool. Phase 2: A separate validation sample completed the same measures as in Phase 1, but was used to assess the model’s specificity/ sensitivity. Results and Discussion: Phase 1: 285 patients were recruited. Acute nausea was reported in 36.5%, 36.5% and 32.3% during cycles one, two and three respectively, whereas delayed nausea was presented in 50.5%, 41.8% and 46.5% respectively. Acute/delayed vomiting was well managed with 7.7–13.3% reporting symptoms over the three cycles. Nausea and/or vomiting was more prevalent in younger (OR = 0.96, p < 0.001) or female patients (OR = 2.14, p = 0.003), patients with higher expectation of nausea (OR = 1.15, p = 0.015), history of nausea and vomiting (OR = 2.37, p < 0.001), higher state (OR = 2.04, p < 0.001) and trait anxiety (OR = 1.97, p = 0.004), higher symptom distress (OR = 2.63, p < 0.001), and use of high emetogenic chemotherapy (OR = 2.12, p = 0.028). Phase 2: 54 patients were recruited to validate the model. The highest sensitivity was achieved in delayed symptoms (88.2%), overall acute/delayed symptoms (85.5%) and acute symptoms (82.6%), with moderate specificity of 41.6%, 41%, and 47.9% respectively. Conclusion: The model for CINV achieves high sensitivity and can be used as a clinical prediction test to a more individualised antiemetic approach. 76 Interference-based Symptom Severity Cut-points for MDASI-BT C. Choi1 , P.R. Sherwood1 , B. Given2,3 . 1 University of Pittsburgh, School of Nursing, Pittsburgh, USA; 2 Michigan State University, Department of Family Medicine, East Lansing, USA; 3 Michigan State University, Research in Nursing, East Lansing, USA Introduction: Determining cut-points for severity of symptoms in persons with cancer is essential in identifying the time and need for intervention. Although prior studies have suggested cut-points for physical symptoms, little data exists supporting cut-points for cognitive symptoms in patients with tumors in the central nervous system. Material and Method: From a longitudinal descriptive study (R01CA117811) data were obtained from 118 persons diagnosed with a primary malignant brain tumor. Symptom severity using the M.D. Anderson Symptom Inventory-Brain Tumor Module
73 Nursing Management of Patients Taking Everolimus – an Oral MTor Inhibitor L. Lemmens1 , J. Van Steijn2 , A. Wojtasik3 . 1 University Hospitals Leuven, Digestive Oncology, Leuven, Belgium; 2 Leids Universitair Medisch Centrum, Klinische Oncologie, Leiden, The Netherlands; 3 GZA Ziekenhuizen Campus Sint-Augustinus, Oncologie, Wilrijk, Belgium Everolimus (Afinitor) is a novel oral targeted therapy that is approved for the treatment of advanced renal cell carcinoma and advanced progressive neuroendocrine tumours of pancreatic origin. A recent study has shown that everolimus in combination with exemestane increases progression free survival, in comparison to exemestane alone, when used in postmenopausal women with ER+HER2− advanced breast cancer, however, everolimus has not yet been approved for this indication. Everolimus is administered once per day. Like all targeted therapies everolimus can cause a number of burdensome side effects that can have a negative impact on patients’ quality of life. Common side effects include stomatitis, fatigue, anaemia, neutropenia (and related infections), thrombocytopenia, diarrhoea, non-infectious pneumonitis, oedema and metabolic disturbances (including hyperglycaemia, hypercholesterolaemia and hypertriglyceridaemia). Whilst some of these side effects overlap with those seen with other cancer drugs, a number are unique to mTOR inhibitors. For example, the aphtous ulceration associated with everolimus is different to the mucositis seen with conventional cytotoxics and non-infectious pneumonitis is a class effect of mTOR inhibitors. Non-infectious pneumonitis is a potentially life-threatening side effect of everolimus that requires close monitoring and prompt intervention. Like many oral targeted therapies everolimus is a substrate of CYP3A4 and there is a risk of interaction when it is taken concomitantly with CYP3A4 inducers and inhibitors (drugs or food). This presentation aims to increase nurses’ knowledge about how to prevent, detect early and effectively manage everolimus-related side effects. Particular emphasis will be placed on how to manage the more unique side effects associated with everolimus such as apthous ulceration, metabolic disturbances and non-infectious pneumonitis. The presentation will also highlight the risk of drug interaction when everolimus is used concomitantly with strong CYP34 inducers/inhibitors where there is a need to consider dose adjustments. In addition, it will be emphasised that everolimus is a continuous, long-term treatment and therefore some patients may struggle with adherence, especially if they have to take other oral medicines. Interventions targeted at promoting medicines adherence such as the provision of tailored patient education, effective side effect management and on-going support will be reviewed. Finally, the presentation will point to the importance of managing everolimus-related side effects within the context of a multidisciplinary team. 74 Comparison of Fatigue of Patients With Cancer and Their Family Caregivers 1 1 ¨ ¨ Usta Yesilbalkan1 , F. Ozdemir . Ege University Faculty of Nursing, O. Izmir, Turkey
Objectives: The purpose of this study was to compare the fatigue of cancer patients and their family caregivers. Methods: A total of 90 paired patients and family caregivers from an outpatient chemotherapy unit of the oncology units were recruited. Both patients and their caregivers completed Fatigue Severity Scale. Independent t-tests were used to test whether a statistically significant difference in the fatigue scores for patients and family caregivers.
S27
Results: The mean age of patients was 51.01 years, and of their family caregivers was 46.38. The results indicated that the patients had higher fatigue scores than their family caregivers. Conclusions: Family caregivers need to be assessed, along with patients, for fatigue, and appropriate interventions initiated for them and for the patient. 75 A Risk Prediction Model of Chemotherapy Related Nausea and Vomiting Z. Stamataki1 , A. Molassiotis1 , E. Kontopantelis2 . 1 University of Manchester, School of Nursing Midwifery and Social Work, Manchester, United Kingdom; 2 University of Manchester, Health Sciences Primary Care Research Group, Manchester, United Kingdom Introduction: While the management of chemotherapy-induced vomiting has improved over the years, with the variation of antiemetic regimens, nausea still remains a significant clinical problem. The study is looking to (a) assess the contribution of clinical, physiological and psychological variables in the development of chemotherapy-related nausea and vomiting, and (b) develop and validate a risk prediction model for CINV. Material and Methods: This is a two phase-prospective, observational, longitudinal study over 3 cycles of chemotherapy. Phase 1: At baseline, patients completed the State-Trait Anxiety Inventory, Symptom Distress Scale and a descriptive questionnaire with their socio-demographics, history of nausea/vomiting and expectation of nausea. At each cycle, patients completed the MASCC Antiemesis Tool. Phase 2: A separate validation sample completed the same measures as in Phase 1, but was used to assess the model’s specificity/ sensitivity. Results and Discussion: Phase 1: 285 patients were recruited. Acute nausea was reported in 36.5%, 36.5% and 32.3% during cycles one, two and three respectively, whereas delayed nausea was presented in 50.5%, 41.8% and 46.5% respectively. Acute/delayed vomiting was well managed with 7.7–13.3% reporting symptoms over the three cycles. Nausea and/or vomiting was more prevalent in younger (OR = 0.96, p < 0.001) or female patients (OR = 2.14, p = 0.003), patients with higher expectation of nausea (OR = 1.15, p = 0.015), history of nausea and vomiting (OR = 2.37, p < 0.001), higher state (OR = 2.04, p < 0.001) and trait anxiety (OR = 1.97, p = 0.004), higher symptom distress (OR = 2.63, p < 0.001), and use of high emetogenic chemotherapy (OR = 2.12, p = 0.028). Phase 2: 54 patients were recruited to validate the model. The highest sensitivity was achieved in delayed symptoms (88.2%), overall acute/delayed symptoms (85.5%) and acute symptoms (82.6%), with moderate specificity of 41.6%, 41%, and 47.9% respectively. Conclusion: The model for CINV achieves high sensitivity and can be used as a clinical prediction test to a more individualised antiemetic approach. 76 Interference-based Symptom Severity Cut-points for MDASI-BT C. Choi1 , P.R. Sherwood1 , B. Given2,3 . 1 University of Pittsburgh, School of Nursing, Pittsburgh, USA; 2 Michigan State University, Department of Family Medicine, East Lansing, USA; 3 Michigan State University, Research in Nursing, East Lansing, USA Introduction: Determining cut-points for severity of symptoms in persons with cancer is essential in identifying the time and need for intervention. Although prior studies have suggested cut-points for physical symptoms, little data exists supporting cut-points for cognitive symptoms in patients with tumors in the central nervous system. Material and Method: From a longitudinal descriptive study (R01CA117811) data were obtained from 118 persons diagnosed with a primary malignant brain tumor. Symptom severity using the M.D. Anderson Symptom Inventory-Brain Tumor Module