Clinical trial NCT06965556: Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Patient Education
Perioperative Care
Psychological Intervention
Keywords: breast carcinoma
patient education
educational comic
psychological intervention
hospitalization
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 1138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: anxiety status at hospital discharge
timeFrame: Five days after surgery
measure: depression severity at hospital discharge
timeFrame: Five days after surgery
measure: sleep quality at hospital discharge
timeFrame: Five days after surgery
Secondary outcomes:
measure: The proportion of patients opting for breast-conserving cosmetic procedures
timeFrame: Five days after surgery
measure: Incidence of postoperative complications requiring surgical intervention
timeFrame: 12 months follow-up
measure: Long-term treatment adherence
timeFrame: 12 months follow-up
measure: Patients' disease-coping resilience
timeFrame: 12 months follow-up
measure: Quality of life assessment at discharge
timeFrame: Five days after surgery
measure: Quality of life assessment
timeFrame: 12 months follow-up
measure: Loss to follow-up rate
timeFrame: 12 months follow-up
measure: Quality of life assessment
timeFrame: 12 months follow-up
measure: Quality of life assessment at discharge
timeFrame: Five days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: