Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Humanities-based Patient Education Strategy.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Patient Education, Perioperative Care, Psychological Intervention. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study to Evaluate the Clinical Significance of Medical Humanities-based Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage
Overview
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
- Other 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
Primary outcome measures
- anxiety status at hospital discharge [Time frame: Five days after surgery]
- depression severity at hospital discharge [Time frame: Five days after surgery]
- sleep quality at hospital discharge [Time frame: Five days after surgery]
Secondary outcome measures (9)
- The proportion of patients opting for breast-conserving cosmetic procedures [Time frame: Five days after surgery]
- Incidence of postoperative complications requiring surgical intervention [Time frame: 12 months follow-up]
- Long-term treatment adherence [Time frame: 12 months follow-up]
- Patients' disease-coping resilience [Time frame: 12 months follow-up]
- Quality of life assessment at discharge [Time frame: Five days after surgery]
- Quality of life assessment [Time frame: 12 months follow-up]
- Loss to follow-up rate [Time frame: 12 months follow-up]
- Quality of life assessment [Time frame: 12 months follow-up]
- Quality of life assessment at discharge [Time frame: Five days after surgery]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06965556 · PE-CAT