肝癌病人參與臨床試驗意願及預測因子之研究

Abstract

肝癌居台灣癌症死因第二位，其復發率及致死率偏高，致不斷地研發新藥，讓癌症病人有機會參與臨床試驗，故本研究旨在探討肝癌病人參與臨床試驗意願的主要預測因素。 本研究為橫斷式調查研究，以臺灣北部某醫學中心之一般外科及胃腸肝膽科之門診肝癌病人為研究對象，採立意取樣，以結構式問卷進行訪談，有效樣本共 195人。參與臨床試驗的意願以二分法(有意願/無意願)以及以李克氏七分法做為評估意願的主為指標。研究工具包括「生活品質-EORTC QLQ-C30及McGill QOL、Mishel疾病不確定感、赫氏希望、社會支持、臨床試驗認知態度以及害怕復發」量表，以IBM SPSS Statistics Grad Pack 23.0及IBM Amos 23.0進行資料統計分析。 研究結果顯示，1.研究對象平均年齡為 54.5歲，男性居多(81.5%)，肝癌第I期(42.6%)及第II期(30.8%)為多數；2. 肝癌病人有參與試驗的意願為66.2% (二分法)，意願程度為5.83±1.66分(李克氏七分法)；3.多元邏輯斯回歸分析發現，影響「參與臨床試驗意願」的重要預測因素為「臨床試驗態度(OR＝43.456)、EORTC QLQ-C30功能層面(OR＝6.771)、有口服標靶治療(OR＝3.205)以及有臨床試驗經驗(OR＝6.144)」；4.逐步回歸分析發現，影響肝癌病人「參與臨床試驗意願程度」的主要預測因素，包括「臨床試驗態度、有臨床試驗經驗、有口服標靶治療以及臨床試驗認知」，有效解釋變異量為25.3%；5.路徑分析發現，肝癌病人參與臨床試驗意願程度之直接正向影響因素為「臨床試驗態度 (γ=0.257)、有臨床試驗經驗 (γ=0.224)、臨床試驗認知 (γ=0.148)以及有口服標靶治療(γ=0.135) 」，間接正向影響因素為「有臨床試驗經驗、臨床試驗認知、未喝酒、社會支持、有配偶、McGill QOL、希望感以及癌症症狀困擾」，間接負向影響因素則為「疾病不確定感、經濟來源他人以及EORTC QLQ-C30症狀層面」。 本研究藉由找出肝癌病人參與臨床試驗意願程度之重要預測因素、直接及間接影響因素，據以發展臨床實務照護指引，做為臨床研究護理師訂定具體且切合受試者需求的照護計畫之參考。

Hepatocellular Carcinoma (HCC) is the second leading cause of cancer death in Taiwan. The recurrence rate and mortality rate of HCC is high, leading to continuous research in the development of new drugs, and providing patients with opportunities to participate in clinical trials. The purpose of this study is to investigate the main predictors of the willingness to participate (WTP) in clinical trials among patients with HCC. This study serves as a cross-sectional survey with purposive sampling used to recruit subjects at the outpatient clinic of General Surgery and Gastroenterology & Hepatology of a medical center in North Taiwan. WTP was dichotomized (willingness/no willingness) and a seven-point Likert scale was adopted as the main index for assessment. The information was collected using structured questionnaires, which include the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), the McGill Quality of Life Questionnaire (MQOL), the Mishel Uncertainty in Illness Scale, the Hearth Hopes Index, the Inventory of Socially Supportive Behaviors, fear of recurrence, knowledge of and attitude towards clinical trials. A total of 195 subjects were analyzed. All data was statistically analyzed with IBM SPSS Statistics Grad Pack 23.0 and IBM Amos 23.0 Windows version. Research results : (1) the average age of subjects was 54.5 years old with a majority being male (81.5%), and tumor node metastasis (TNM) stage I (42.6%) and stage II (30.8%) as the main stages; (2) the willingness for HCC patients to participate in trials was 66.2% (dichotomy) and the level of willingness was 5.83±1.66 points (seven-point Likert scale); (3) through multiple logistic regression analysis it was found that important predictors influencing “willingness to participate in clinical trials” are “clinical trial attitudes” (OR=43.456), “EORTC QLQ-C30 functional scales” (OR=6.771), “treatment with oral targeted therapy” (OR=3.205), and “previous trial participation” (OR=6.144); (4) through stepwise regression analysis “the level of willingness to participate in clinical trials” was showed that the main predictors include “clinical trial attitudes,” “previous trial participation,” “treatment with oral targeted therapy,” and “clinical trial knowledge” with an effective variance explained of 25.3%; and (5) through the path analysis, we discovered that direct positive factors influencing HCC patients’ the level of willingness to participate in clinical trials are “clinical trial attitudes” (γ=0.257), “previous trial participation” (γ=0.224), “clinical trial knowledge” (γ=0.148), and “treatment with oral targeted therapy” (γ=0.135); indirect positive factors are “previous trial participation,” clinical trial knowledge,” “ lifetime abstainers,” “social support,” “spouse,” “MQOL,” “hope,” and “cancer symptom distress”; and indirect negative factors are “uncertainty of illness ,” “financial resources of others,” and “EORTC QLQ-C30 symptom scales.” By identifying the important predictors as well as directly and indirectly influencing factors, the guideline of clinical practice care can be developed in accordance with the results and serves as a reference for clinical research nurses (CRN) in formulating a patient-specific care plans that meets the needs of subjects.