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NCT Number: NCT06965556

Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage

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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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Patient Education Perioperative Care Psychological Intervention Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. anxiety status at hospital discharge

    Time frame: 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

  2. depression severity at hospital discharge

    Time frame: 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.

  3. sleep quality at hospital discharge

    Time frame: 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 outcomes

  1. The proportion of patients opting for breast-conserving cosmetic procedures

    Time frame: Five days after surgery

    including breast-conserving surgery, oncoplastic breast-conserving surgery, implant-based or autologous breast reconstruction

  2. Incidence of postoperative complications requiring surgical intervention

    Time frame: 12 months follow-up

    Incidence of postoperative complications requiring surgical intervention within 12 months after surgery

  3. Long-term treatment adherence

    Time frame: 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.

  4. Patients' disease-coping resilience

    Time frame: 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).

  5. Quality of life assessment at discharge

    Time frame: 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)

  6. Quality of life assessment

    Time frame: 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)

  7. Loss to follow-up rate

    Time frame: 12 months follow-up

    Loss to follow-up rate between study groups at 12-month follow-up

  8. Quality of life assessment

    Time frame: 12 months follow-up

    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)

  9. Quality of life assessment at discharge

    Time frame: Five days after surgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajian Chen, MD

CONTACT

[email protected]

862164175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Prospective Study to Evaluate the Clinical Significance of Medical Humanities-based Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage

Acronym: PE-CAT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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