Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• anxiety status at hospital discharge [Срок оценки: Five days after surgery]
• depression severity at hospital discharge [Срок оценки: Five days after surgery]
• sleep quality at hospital discharge [Срок оценки: Five days after surgery]

Вторичные конечные точки (9)

• The proportion of patients opting for breast-conserving cosmetic procedures [Срок оценки: Five days after surgery]
• Incidence of postoperative complications requiring surgical intervention [Срок оценки: 12 months follow-up]
• Long-term treatment adherence [Срок оценки: 12 months follow-up]
• Patients' disease-coping resilience [Срок оценки: 12 months follow-up]
• Quality of life assessment at discharge [Срок оценки: Five days after surgery]
• Quality of life assessment [Срок оценки: 12 months follow-up]
• Loss to follow-up rate [Срок оценки: 12 months follow-up]
• Quality of life assessment [Срок оценки: 12 months follow-up]
• Quality of life assessment at discharge [Срок оценки: Five days after surgery]

Критерии участия

Критерии включения

• 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
• Patients to receive breast surgery during hospitalizaiton (including mastectomy, breast conserving therapy, reconstrucion, etc.)
• Be able and willing to sign the Informed Consent Form (ICF)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06965556 · PE-CAT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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