The efficacy of radiotherapy and the satisfaction of patients can be significantly improved by adequately addressing their information needs. This process is impeded by the current lack of a comprehensive tool for assessing these needs. To develop an Information Needs Questionnaire for patients with breast cancer undergoing radiotherapy and to assess its reliability and validity. The initial item pool for the questionnaire was developed through a literature analysis and semi-structured interviews with 12 patients with breast cancer receiving radiotherapy. The Delphi method was employed to consult 16 experts and the questionnaire content was refined based on expert feedback and item ratings to form the first draft. A pre-investigation was conducted on 30 patients with breast cancer treated with radiotherapy to refine the item expression. From March-October 2024, item analysis, factor analyses, and reliability tests were conducted on 220 patients. This study adhered to STROBE guidelines. The final questionnaire comprised 36 items. Exploratory factor analysis revealed 5 dimensions, with all item factor loading within their respective dimensions being ≥ 0.4 and no items exhibiting multiple loadings. These five factors accounted for 72.805% of the total variance. The overall content validity index was 0.980, with item-level content validity index ranging from 0.900 to 1.000. The Cronbach's α coefficient for the entire questionnaire was 0.959, and the coefficients for each dimension ranged from 0.786 to 0.958. The Information Needs Questionnaire demonstrated excellent reliability and validity in patients with breast cancer undergoing radiotherapy. It can effectively guide medical staff to accurately assess the information needs of patients with breast cancer who are undergoing radiotherapy. Identifying the authentic informational needs of breast cancer patients throughout the entire radiotherapy process is instrumental in enabling medical staff to devise personalised and targeted information support interventions. A total of 220 participants provided perspectives on their information needs.
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