參與臨床試驗的肺癌病人不確定感與希望狀態之探討

Abstract

本研究目的為瞭解參與臨床試驗的肺癌病人不確定感與希望狀態。採橫斷式、描述性相關性之設計，以立意取樣，於北部某一家醫學中心之腫瘤科與胸腔科門診、臨床試驗病房、及門診化學藥物治療室收案。研究工具包括個人基本資料表、赫氏希望指標中文版量表、Mishel疾病不確定感中文量表。所收集的資料以描述性統計、T檢定、單因子變異數分析、皮爾森積差相關、及複迴歸等統計方式進行資料處理，並加以分析。 本研究共收案100位肺癌且正參與臨床試驗病人，結果發現研究對象不確定感的平均得分為59.71分(59.71分/125分=47.77%)，屬於中等程度；影響不確定感的相關因素有：教育年數、職業狀況、曾參與臨床試驗經驗、自覺病情嚴重程度、目前的身體功能狀態、參與試驗的天數、參與此次臨床試驗的期待、對試驗內容了解程度及試驗計畫書對試藥藥物的預期效果。研究對象希望狀態的平均得分為29.10分(29.1分/40=72.75%)，屬於中高等程度；影響希望狀態的相關因素有：教育年數、職業狀況、曾參與臨床試驗經驗、自覺病情嚴重程度、參與此次臨床試驗的期待、對試驗內容了解程度。不確定感與希望狀態之關係，兩者呈現高度的負相關，不確定感為希望狀態之預測因子，可解釋30%的變異量。 本研究結果有助於臨床護理人員與臨床研究護理師瞭解，參加臨床試驗的肺癌病人不確定感和希望狀態的情形及之間的相關性，提供臨床研究護理師未來在照護試驗病人時，在解釋試驗同意書時能發揮同理心的溝通技巧了解病人的擔心與期待適當的給予情緒上的支持且依病人不同的經驗給予個別化的照護；對於臨床護理人員在照顧參與臨床試驗的病人能提供更多的幫助。對於未來的研究可設計介入措施，以改善病人不確定感與希望狀態，提升癌症病人的照護品質。

The purpose of this study was to explore the uncertainty and hope status of the patients with lung cancer participating in clinical trials. This study was a cross-sectional descriptive correlational design. A purposive sampling was used to recruit the patients at oncology ward, chest outpatient department, clinical trial ward, and chemotherapy rooms of medical center in northern Taiwan. Data were collected by using medical chart information, Mishel Uncertainty in Illness Scale (MUIS), Herth Hope Index (HHI). It was analyzed by using descriptive statistics, T test, one way-ANOVA, Pearson’s correlation and multiple regression analysis. A total of 100 subjects with lung cancer and enrolled in clinical trial were recruited and analyzed. The result of this study were as below, the mean score of the Uncertainty in Illness was 59.71 (59.71/125=47.77%); the related factors of uncertainty were years of education, occupational status, experiences of involved in clinical trials, self-awareness of disease severity, recent performance status, the length of participating this clinical trial, patient expectations of benefit from clinical trial, the understanding of clinical trial, the expected benefits of investigational product. The mean score of the hope was 29.10 (29.1/40=72.75%); the related factors of hope were years of education, occupational status, experiences of involved in clinical trials, self-awareness of disease severity, patient expectations of benefit from clinical trial, the understanding of clinical trial. The relation of uncertainty and hope status was significantly negative correlated and the uncertainty was a predictor of hope, which could explain 30% of the variance. The findings of this study could help practice nurse and clinical research nurse to understand the relation of uncertainty and hope status for patients of lung cancer who participating in clinical trials, afford information to clinical research nurse in caring clinical subjects, such as using empathy in explain inform consent form, understanding the uncertainty and hope, giving the emotion support and offer the individualized care. We expect the findings could be useful for the clinical research nurse and they could offer more sufficient help to patients. Future interventional studies should be designed in order to improve the uncertainty and hope status of patients and to enhance the quality of care for cancer patients.