Breast Carcinoma, Patient Education, Perioperative Care, Psychological Intervention
Conditions
Keywords
breast carcinoma, patient education, educational comic, psychological intervention, hospitalization
Brief 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.
Interventions
OTHERMedical Humanities-based Patient Education Strategy
Medical Humanities-based Patient Education with Comic-based Medical Education Materials for Breast Cancer Patients during Perioperative Hospitalization Stage
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anxiety status at hospital discharge | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' disease-coping resilience | 12 months follow-up | 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). |
| Quality of life assessment at discharge | Five days after surgery | 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) |
| The proportion of patients opting for breast-conserving cosmetic procedures | Five days after surgery | including breast-conserving surgery, oncoplastic breast-conserving surgery, implant-based or autologous breast reconstruction |
| Loss to follow-up rate | 12 months follow-up | Loss to follow-up rate between study groups at 12-month follow-up |
| Quality of life assessment | 12 months follow-up | 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) |
| Incidence of postoperative complications requiring surgical intervention | 12 months follow-up | Incidence of postoperative complications requiring surgical intervention within 12 months after surgery |
| Long-term treatment adherence | 12 months follow-up | 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. |
Countries
China
Contacts
Primary ContactJiajian Chen, MD
Outcome results
None listed