The Study of the Willingness to Participate in Clinical Trials and Predictors among Patients with Hepatocellular Carcinoma

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.