Development and validation of a drug clinical trial participation feelings questionnaire for cancer patients.

ABSTRACT

Objective: The study was designed to develop and validate a new drug clinical trial participation feelings questionnaire (DCTPFQ) for cancer patients. Methods: 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. Results: 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). Conclusion: The DCTPFQ is a useful tool for measuring the drug clinical trial participation feelings among cancer patients.