NCT06965556

Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage

A Prospective Study to Evaluate the Clinical Significance of Medical Humanities-based Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,138 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction 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 and Analysis 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. Ethics and Dissemination Approved by the FUSCC ethics committee, all participants provide informed consent. Results will be disseminated through international conferences and peer-reviewed journals. The study adheres to ethical guidelines, ensuring data confidentiality via encrypted platforms. Authors declare no conflicts of interest, supported by Shanghai Municipal Science and Technology Innovation Action Plan (24DZ2303500). Findings aim to optimize perioperative education strategies, addressing psychological and informational needs of breast cancer patients.

Conditions

• Breast Carcinoma
• Patient Education
• Perioperative Care
• Psychological Intervention

Interventions

Type	Name	Description
OTHER	Medical Humanities-based Patient Education Strategy	Medical Humanities-based Patient Education with Comic-based Medical Education Materials for Breast Cancer Patients during Perioperative Hospitalization Stage

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2025-05-11
• Last updated: 2025-05-13

Locations

1 site across 1 country: China