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

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...

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Bibliographic Details
Published in:Frontiers in pharmacology 2024-06, Vol.15, p.1371811
Main Authors: Guo, Chaowei, Xing, Shujun, Zhao, Guo, Wu, Dawei, Li, Ning, Wang, Shuhang, Yu, Ling
Format: Article
Language:English
Subjects:
cancer nursing
clinical trials
education
nursing
participation feelings
Pharmacology
Online Access:Get full text
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Summary: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, < 0.05) and the Mishel's Uncertainty in Illness Scale (r = 0.714, < 0.05). The DCTPFQ is a useful tool for measuring the drug clinical trial participation feelings among cancer patients.
ISSN:1663-9812
1663-9812
DOI:10.3389/fphar.2024.1371811