A Prospective, Non-randomized, Open-label Study to Evaluate the Clinical Significance of Medical Humanities-based Patient Education Strategy for Operable Breast Cancer Patients during Perioperative Hospitalization Stage (PE-CAT trial)

Background Breast cancer remains a leading global health concern, with significant psychological challenges during the perioperative period. Traditional patient education focuses on disease management but often neglects emotional and cognitive needs. Perioperative inpatients are relatively stable and have the time and mental space for deeper education and psychological support. This study evaluates the clinical significance of a medical humanities-based education strategy for breast cancer patients during hospitalization, aiming to enhance psychological resilience, treatment adherence, and quality of life. Methods This prospective, non-randomized, open-label study will include female patients with early-stage breast cancer scheduled for surgery at Fudan University Shanghai Cancer Center. Participants will be allocated to two cohorts: practical education group and mental enhanced group. The primary endpoint is psychological assessment at hospital discharge, including anxiety (GAD-7), depression (PHQ-9), and sleep quality (ISI). Secondary endpoints include the proportion of patients opting for breast-conserving procedures, incidence of postoperative complications, long-term treatment adherence (MMAS-8), patients' disease-coping resilience (CD-RISC-10), and quality of life assessment (EORTC QLQ instruments) at 12-month follow-up. Data collection and statistical analysis will be conducted using validated instruments and software, with significance set at p ≤ 0.05. Discussion The present study comprehensively assesses the effects of various perioperative patient educational approaches on patient management across multiple domains. This multidimensional evaluation incorporates both psychological state modulation during initial diagnostic phases and longitudinal monitoring of treatment adherence and psychological resilience. The result of the study will provide solid evidence for building a patient education strategy that better aligns with modern breast health management concepts. It is expected to promote the optimization and upgrading of perioperative breast cancer patient management models. Trial Registration NCT06965556, ClinicalTrials.gov