Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

Qualifiers

More than 18 years old

Female

Patient with early-stage breast cancer with preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ

No clinical or imaging evidence of distant metastasis

Disqualifiers

Patients with locally advanced breast cancer to receive neoadjuvant therapy

Patients currently participating in other clinical trials, which may have impact on the participation in this trial

Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)

Trial design

Treatments tested in this trial

  • Medical Humanities-based Patient Education Strategy

Treatment groups

1,138 Participants
are divided into 2 treatment groups

Sponsors and collaborators