Development and initial validation of a scale assessing sources of decision hesitation in patients with lung cancer invited to participate in drug clinical trials.

Abstract

To develop and preliminarily validate a theory-driven, nursing-relevant scale measuring sources of decision hesitation for patients with lung cancer who have been invited to participate in drug clinical trials. A two-stage cross-sectional study was conducted between April 2024 and September 2025. The initial item pool was established via literature review and semi-structured patient interviews. Two rounds of Delphi consultation and pre-testing were conducted to form the preliminary scale. A total of 407 eligible patients with lung cancer from a tertiary hospital in Sichuan were enrolled. Exploratory and confirmatory factor analyses, correlation analysis and reliability tests were performed to verify scale psychometric properties. The final 23-item scale captures six key sources of decision hesitation: perceived trial risk, perceived trial value, perceived patient-physician trust, perceived family influence, perceived resource barriers, and perceived self-efficacy. The six-factor model showed acceptable fit indices. The scale demonstrated good content validity (scale-level content validity index [S-CVI] = 0.97), convergent validity (<i>r</i> = 0.471 with the Decisional Conflict Scale), internal consistency (Cronbach's &#x3b1; = 0.929), and test-retest reliability (intraclass correlation coefficient [ICC] = 0.779). This study provides initial psychometric evidence for a scale capturing six key sources of decision hesitation among patients with lung cancer invited to participate in drug clinical trials. The scale shows promise as a screening and supportive assessment tool; however, further prospective, multicenter validation is required to confirm its predictive validity and generalizability. This study was registered with the China Clinical Trial Registry (Registration No. ChiCTR2400093749).