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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Medical Humanities-based Patient Education Strategy
Other interventionMedical Humanities-based Patient Education with Comic-based Medical Education Materials for Breast Cancer Patients during Perioperative Hospitalization Stage
Treatment groups
1,138 Participants
are divided into 2 treatment groupsGroup A: Medical Humanities-based Patient Education StrategyActive comparator 1 intervention
Group B: Routine Patient Education StrategyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Five days after surgery2
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.
Time frame
Five days after surgery3
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.
Time frame
Five days after surgerySecondary outcomes
1
The proportion of patients opting for breast-conserving cosmetic procedures
including breast-conserving surgery, oncoplastic breast-conserving surgery, implant-based or autologous breast reconstruction
Time frame
Five days after surgery2
Incidence of postoperative complications requiring surgical intervention
Incidence of postoperative complications requiring surgical intervention within 12 months after surgery
Time frame
12 months follow-up3
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.
Time frame
12 months follow-up4
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).
Time frame
12 months follow-upSponsors and contacts
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Source ClinicalTrials.gov
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