该研究旨在开发和验证针对癌症患者的新药临床试验参与感受问卷（DCTPFQ）。数据收集和分析涉及定性和定量相结合的方法。这项研究分为两个阶段。第一阶段涉及制定一份调查问卷，以确定要包含在池中的项目清单：基于转换理论和罗珀-洛根-蒂尔尼理论构建了理论框架。在纳入理论框架、采访参与者并查阅文献后，生成了 44 项。经过德尔菲咨询和试点，对36个项目进行了项目分析和探索性因素分析（EFA），形成了21个项目的四因素结构。在第二阶段进行了验证性因素分析（CFA）、重测信度、标准相关效度和内部一致性测试，以检查心理测量特性。 DCTPFQ 有 21 个项目，范围从 1（完全不同意）到 5（完全同意）。通过EFA和CFA，可以验证DCTPFQ的四个因素，包括认知投入、主观体验、医疗资源和亲友支持。 DCTPFQ 的重测信度为 0.840，Cronbach's alpha 为 0.934。 DCTPFQ 与简式恐惧进展问卷 (r = 0.731，p < 0.05) 和 Mishel 疾病不确定性量表 (r = 0.714，p < 0.05) 显着相关。 DCTPFQ 是衡量药物临床的有用工具。癌症患者的试验参与感受。版权所有 © 2024 郭、兴、赵、吴、李、王和余。

The study was designed to develop and validate a new drug clinical trial participation feelings questionnaire (DCTPFQ) for cancer patients.Data collection and analysis involved a combination of qualitative and quantitative methods. There were two phases to this study. Phase Ⅰ involved developing a questionnaire to establish a list of items to be included in the pool: A theoretical framework was constructed based on the transitions theory and the Roper-Logan-Tierney theory. After incorporating a theoretical framework, interviewing participants, and reviewing the literature, 44 items were generated. After a Delphi consultation and a pilot test, 36 items proceeded to item analysis and exploratory factor analysis (EFA), and a four-factor structure with 21 items was formed. Confirmatory factor analysis (CFA), test-retest reliability, criteria-related validity, and internal consistency tests were conducted in phase II to examine the psychometric properties.There were 21 items on the DCTPFQ, ranging from 1 (fully disagree) through 5 (fully agree). As a result of EFA and CFA, the four factors of DCTPFQ could be verified, including cognitive engagement, subjective experience, medical resources, and relatives and friends' support. Test-retest reliability of the DCTPFQ was 0.840, and Cronbach's alpha was 0.934. DCTPFQ is significantly correlated with the Fear of Progression Questionnaire-short form (r = 0.731, p < 0.05) and the Mishel's Uncertainty in Illness Scale (r = 0.714, p < 0.05).The DCTPFQ is a useful tool for measuring the drug clinical trial participation feelings among cancer patients.Copyright © 2024 Guo, Xing, Zhao, Wu, Li, Wang and Yu.