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문제 정의
- This study aimed to provide basic data regarding the management of CIPN-related symptoms in patients with hematologic malignancies receiving therapy with neurotoxic agents. Manifested peripheral neuropathy characteristics were itemized by performing a secondary data analysis according to the study by Kim et al.
- This study was a descriptive survey study, which aimed to determine the characteristics of CIPN and the degree of QOL experienced by patients with hematologic malignancies treated with neurotoxic chemotherapeutic agents.
제안 방법
- Data were collected from January to May 2013 and the researcher collected the data by using the questionnaire targeting for the outpatients who visited the Division of Hematology of the C National University H Hospital and the inpatients who are receiving the chemotherapy. All patients underwent neurological examination by an oncologist to assess the presence of CIPN. Those who had shown symptoms before being exposed to chemotherapeutics were excluded from the study.
- Inclusion criteria for this study were an age 18 years, medical records showing treatment with 1 or more neurotoxic chemotherapeutic agents, including vincristine, thalidomide, bortezomib, and lenalidomide, and the experience of peripheral neuropathy. The presence or absence of symptoms was verified in screened patients and, among patients with symptoms, those who understood the purpose of this study and agreed to participation were included.
- It took participants an average of 15~20 minutes to complete the study questionnaire consisting of items about participants’ general and clinical characteristics and two instruments from the EORTC, QLQ-CIPN20 and QLQ-C30.
- Limitations of this study include the fact that its sample size of 66 participants was not large enough for a secondary data analysis, and its nonparametric analytical tests raise an interpretational issue with regard to the study results. Additionally, a replication study is necessary to focus on the high-risk factors and comorbid diseases as influential factors for CIPN (e.
- The 2 global health status-related items were designed for a 7-point answer scale, while all other items were designed for a 4-point scale. Scores were converted to a 100-point scale according to the scoring manual[25], with the QOL increasing in proportion to the global health status and functional scale scores. In contrast, the lower the symptom scales score, the higher the QOL.
- The global health status scale comprised 2 items (1 health status and 1 QOL item), the functional scale comprised 15 items (5 physical, 2 role, 4 emotional, 2 cognitive, and 2 social items), and the symptom scale comprised 13 items (3 fatigue, 2 nausea/vomiting, 2 pain, 1 dyspnea, 1 insomnia, 1 appetite loss, 1 constipation, 1 diarrhea, and 1 financial problem item). The 2 global health status-related items were designed for a 7-point answer scale, while all other items were designed for a 4-point scale. Scores were converted to a 100-point scale according to the scoring manual[25], with the QOL increasing in proportion to the global health status and functional scale scores.
- ,[24]. The original EORTC QLQ-CIPN20, developed by Postma et al.,[2] as a subscale of the European Organization for the Research and Treatment of Cancer quality of life questionnaire core 30 items (EORTC QLQ-30), was comprised of 20 questions (on a 4-point Likert scale) that assessed CIPN, and included 3 subscales to assess motor (8 items), sensory (9 items), and autonomic (3 items) symptoms, as well as function [2]. Three items from the autonomic scale ("Were you dizzy when standing up from a sitting or lying position?", "Did you have blurred vision?", and "Did you have difficulty getting or maintaining an erection?") and 1 item from the sensory scale (Did you have difficulty hearing?) were eliminated from the 20-item original tool because of low inter-item correlations[24].
- The questionnaire form contained 13 questions concerning gender, age, education level, employment status, Eastern Cooperative Oncology Group performance status (ECOG PS), diagnosis, duration of diagnosis, current chemotherapy, duration of CIPN, and exposure to neurotoxic agents.
- To express the participants’ degrees of CIPN-related symptoms and health-related QOL, the means and standard deviations were computed.
대상 데이터
- Data were collected from January to May 2013 and the researcher collected the data by using the questionnaire targeting for the outpatients who visited the Division of Hematology of the C National University H Hospital and the inpatients who are receiving the chemotherapy. All patients underwent neurological examination by an oncologist to assess the presence of CIPN.
- First, this study evaluated only 16 of the 20 original items of the EORTC QLQ-CIPN20 tool[24] as four items were deleted during the validity test. To justify the elimination of these 4 items as non-CIPN-related problems, Smith et al[24].
- This study included patients with hematologic malignancies and a high possibility of comorbid anemia, a high proportion of elderly patients (47%≥65 years of age), and patients unexposed to chemotherapeutics associated with ototoxicity.
데이터처리
- The differences in scores between the CIPN-related symptoms and health-related QOL according to the participants’ general and clinical characteristics were analyzed using the Mann-Whitney and Kruskal-Wallis tests.
이론/모형
- CIPN was assessed using the 16-item QLQ-CIPN20, which was validated by Smith et al.,[24]. The original EORTC QLQ-CIPN20, developed by Postma et al.
- To assess health-related QOL, we used the Korean version of the EORTC QLQ-C30 (3.0 version)[26], which was translated from the validity-tested QLQ-C30 (3.0 version) developed by the EORTC. This tool comprised 3 subscales: the global health status, functional, and symptom scales.
성능/효과
- , and Wolf et al[27]., this study determined the most common CIPN-related symptom among participants to be numbness, followed by tingling and shooting/burning pain. And, the mean CIPN scores for the lower and upper extremity scales as in this study were 31.
- , this study determined the most common CIPN-related symptom among participants to be numbness, followed by tingling and shooting/burning pain. And, the mean CIPN scores for the lower and upper extremity scales as in this study were 31.95 and 23.16 points, respectively, demonstrating more severe CIPN-related symptoms in the lower extremities. These results are similar to those of previous studies[1, 27], which CIPN-related symptoms were more frequent and intense in the lower extremities than in the upper extremities.
- 008). For the functional scale scores according to general and clinical characteristics, significant mean rank differences existed for age (p=.014), education (p=.015), ECOG PS (p=.018), duration of diagnosis (p=.027), duration of CIPN (p= .008), and exposure to neurotoxic agents (p=.015). In addition, for the symptom scale scores according to general and clinical characteristics, significant mean rank differences existed for current chemotherapy (p=.
- It is known that there is a significant correlation between CIPN and QOL[11-14]. In this study, as CIPN symptoms in the lower extremities become more severe, global health status and functional performance are lower and overall symptoms are severe. But, CIPN symptoms in the upper extremities showed no correlation with quality of life.
- Furthermore, in patients with hematologic malignancies who have been administered neurotoxic chemotherapeutic agents, CIPN assessment must accompany a comparison of the lower and upper extremity symptoms[21]. Moreover in this study, the lower extremity scale scores were significantly different with regard to age, education, ECOG PS, diagnosis, duration of diagnosis, duration of CIPN, and exposure to neurotoxic agents. The results of this study have supported the previous studies[11,21,28] that reported that CIPN level is related to age, ECOG PS, duration of diagnosis, duration of CIPN, and exposure to neurotoxic chemotherapeutic agents.
- 16 points). Of the symptom scales, fatigue and financial problems had relatively high scores (55.22 and52.53 points, respectively), and nausea/vomiting and diarrhea had low scores (11.11 and 12.12 points, respectively) (Table 2).
- The average global health status, functional, and symptoms scale scores of the health-related QOL were 46.84, 58.72, and 34.85 points, respectively. Of the functional scale subscales, the emotional scales were the highest (71.
- The mean QOL scores of our study participants were 46.84 points for the global health status scales, 58.72 points for the functional scales, and 34.85 points for the symptom scales. According to a study on the QOL of oxaliplatin-treated colorectal patients conducted by Kim et al.
후속연구
- Limitations of this study include the fact that its sample size of 66 participants was not large enough for a secondary data analysis, and its nonparametric analytical tests raise an interpretational issue with regard to the study results. Additionally, a replication study is necessary to focus on the high-risk factors and comorbid diseases as influential factors for CIPN (e.g., diabetes, a cumulative dose of neuro-toxic chemotherapeutic agents, etc.), which could not be addressed in this study. Thus, a replication study is necessary to focus on high-risk factors and comorbid diseases as influential factors for CIPN.
- Furthermore, it is necessary to develop effective pharmacological and non-pharmacological interventions to prevent and alleviate CIPN-related symptoms. Finally, this study was not able to consider all of the variables that may affect CIPN. Future studies should include co-morbid diseases and high risk factors in order to identify the effect factors of CIPN in patients with hematologic malignancies.
- Finally, this study was not able to consider all of the variables that may affect CIPN. Future studies should include co-morbid diseases and high risk factors in order to identify the effect factors of CIPN in patients with hematologic malignancies.
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