Culturally Adapted Shared Decision-Making Tool for Breast Cancer Clinical Trials in China: A Nurse-Led Approach

This study aimed to develop and validate a culturally adapted, nurse-led shared decision-making question prompt list (SDM-QPL) to enhance decision-making support for Chinese breast cancer patients considering clinical trials. A mixed-methods approach was employed, involving a systematic literature review (52 studies), semi-structured interviews with 15 patients and 8 healthcare providers, a three-round Delphi consensus with 13 experts, and psychometric testing. The process yielded a 40-item QPL tailored to cultural needs, such as familial decision-making and Traditional Chinese Medicine (TCM) use. The SDM-QPL, organized into five modules, achieved strong expert consensus (Kendall's W = 0.82, P < 0.001) and retained 92% of nurse-sensitive items. Psychometric evaluation confirmed high validity (S-CVI/Ave = 0.89) and reliability (Cronbach's α = 0.91). Qualitative analysis identified key barriers: information overload (93.3%), risk misperceptions (86.7%), and nursing communication gaps (80.0%). This nurse-led SDM-QPL, grounded in Elwyn's Three-Talk Model, addresses China's unique cultural and structural challenges, fostering triadic dialogue among patients, families, and providers. The tool empowers oncology nurses to bridge communication gaps, improve trial participation equity, and support patient-centered care in collectivist settings.