A Prospective Study to Evaluate the Clinical Significance of Medical Humanities-based Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,138
- 试验地点
- 1
- 主要终点
- anxiety status at hospital discharge
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old
- •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)
排除标准
- •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)
研究组 & 干预措施
Medical Humanities-based Patient Education Strategy
Mental Enhanced Education Strategy
Patients allocated to the enhanced mental health education intervention cohort will receive supplemental medical humanities modules alongside the standard Practical Education Strategy during hospitalization. This content is derived from a comic publication compiled by the breast surgery team of Fudan University Shanghai Cancer Center, which narrates the 4600-year human battle against breast cancer in a grand story. The content combines humorous cartoons with novel-like text, covering the evolution of human understanding of breast cancer, and the emergence and development of various therapies, drugs, and technologies. For patients unable to read, audio books and dynamic cartoon videos are available on mobile devices. The general content framework is as follows:
- Understanding of breast cancer in ancient Egypt and Persia;
- Hippocratic-Galenic Theories: early management of breast disorders in Greco-Roman antiquity;
- Traditional Chinese medical interpret
干预措施: Medical Humanities-based Patient Education Strategy (Other)
Routine Patient Education Strategy
Practical Education Strategy
Admission Day
- Comprehensive admission nursing assessment and introduction to care protocols: Admission assessment form, nutritional assessment, fall risk assessment, deep vein thrombosis risk assessment, pain assessment, etc.
- Orientation to ward environment and policies: introduction to the medical team, online doctor-patient communication platform, ward facilities, daily routines, dietary guidelines, and other essential services, etc.
- Review of medical history and guidance on preoperative examinations and precautions: Hematological tests, electrocardiogram, ultrasound, mammography, CT, MRI, core needle biopsy, fine needle aspiration, etc.
Days Before Surgery
- Personal preparation instructions: Bathing, hair washing, fasting, and fluid restriction guidelines, etc.
- Interpretation of preoperative examination results.
- Overview of common surgical approaches for breast cancer, introduction of surgery options based on the condition, especially emphasis on
结局指标
主要结局
anxiety status at hospital discharge
时间窗: Five days after surgery
anxiety status at hospital discharge evaluated using the GAD-7 questionnaire Generalized Anxiety Disorder scale, GAD-7 (0-21 points): Cut-off values of 5, 10, and 15 delineated mild, moderate, and severe anxiety
depression severity at hospital discharge
时间窗: Five days after surgery
depression severity at hospital discharge assessed with the PHQ-9 instrument Patient Health Questionnaire, PHQ-9 (0-27 points): Thresholds at 5, 10, 15, and 20 classified mild, moderate, moderately severe, and severe depression.
sleep quality at hospital discharge
时间窗: Five days after surgery
sleep quality at hospital discharge measured via the ISI scale Insomnia Severity Index, ISI (0-28 points): Scores ≥8, ≥15, and ≥22 indicated subthreshold, moderate, and severe insomnia.
次要结局
- Quality of life assessment at discharge(Five days after surgery)
- Quality of life assessment(12 months follow-up)
- The proportion of patients opting for breast-conserving cosmetic procedures(Five days after surgery)
- Incidence of postoperative complications requiring surgical intervention(12 months follow-up)
- Long-term treatment adherence(12 months follow-up)
- Patients' disease-coping resilience(12 months follow-up)
- Loss to follow-up rate(12 months follow-up)
研究者
Jiong Wu
Principal Investigator
Fudan University