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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Humanities-based Patient Education Strategy | Active Comparator | 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:
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| Routine Patient Education Strategy | No Intervention | Practical Education Strategy Admission Day
Days Before Surgery
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Humanities-based Patient Education Strategy | Other | Medical Humanities-based Patient Education with Comic-based Medical Education Materials for Breast Cancer Patients during Perioperative Hospitalization Stage |
| Measure | Description | Time Frame |
|---|---|---|
| anxiety status at hospital discharge | 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 | Five days after surgery |
| depression severity at hospital discharge | 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. | Five days after surgery |
| sleep quality at hospital discharge | 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. | Five days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients opting for breast-conserving cosmetic procedures | including breast-conserving surgery, oncoplastic breast-conserving surgery, implant-based or autologous breast reconstruction | Five days after surgery |
| Incidence of postoperative complications requiring surgical intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiajian Chen, MD | Contact | 862164175590 | elwin1020@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Incidence of postoperative complications requiring surgical intervention within 12 months after surgery |
| 12 months follow-up |
| Long-term treatment adherence | Long-term treatment adherence evaluation at the 12-month postoperative follow-up (assessed using the MMAS-8 scale) 8-item Morisky Medication Adherence Scale, MMAS-8 (0-8 points): Medication adherence was categorized as optimal (≥6) or suboptimal. | 12 months follow-up |
| Patients' disease-coping resilience | Patients' disease-coping resilience at 12 months postoperatively (evaluated with the CD-RISC-10 instrument) (10-item Connor-Davidson Resilience Scale, CD-RISC-10 (0-40 points): Psychological resilience was dichotomized using the 29.5 threshold (high vs. low resilience). | 12 months follow-up |
| Quality of life assessment at discharge | Quality of life assessment (EORTC QLQ-BR23) at discharge EORTC QLQ instruments (BR23 breast-specific module): Quality-of-life metrics were standardized using European Organization for Research and Treatment of Cancer linear transformation protocols (0-100 scoring) | Five days after surgery |
| Quality of life assessment | Quality of life assessment (EORTC BR45) 1 year postoperatively EORTC QLQ instruments (BR45 comprehensive module): Quality-of-life metrics were standardized using European Organization for Research and Treatment of Cancer linear transformation protocols (0-100 scoring) | 12 months follow-up |
| Loss to follow-up rate | Loss to follow-up rate between study groups at 12-month follow-up | 12 months follow-up |
| Quality of life assessment | Quality of life assessment (EORTC QLQ-C30) 1 year postoperatively EORTC QLQ instruments (C30 core module): Quality-of-life metrics were standardized using European Organization for Research and Treatment of Cancer linear transformation protocols (0-100 scoring) | 12 months follow-up |
| Quality of life assessment at discharge | Quality of life assessment (EORTC QLQ-C30/BR45) at hospital discharge EORTC QLQ instruments (C30 core module): Quality-of-life metrics were standardized using European Organization for Research and Treatment of Cancer linear transformation protocols (0-100 scoring) | Five days after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |