Breast CarcinomaPE-CATNCT06965556
Patient Education Strategy for Breast Cancer Patients During Perioperative Hospitalization Stage
A study testing Medical Humanities-based Patient Education Strategy in people with Breast Carcinoma and Patient Education, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Patient Education, Perioperative Care
- What is being tested?
- Medical Humanities-based Patient Education Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,138 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, 200032
Jiajian Chen, MD, +8618221810450, elwin1020@163.com
About this study
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
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.
- Being tested
- Medical Humanities-based Patient Education Strategy
- Keywords
- breast carcinoma, patient education, educational comic, psychological intervention, hospitalization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Humanities-based Patient Education StrategyOther
Medical Humanities-based Patient Education with Comic-based Medical Education Materials for Breast Cancer Patients during Perioperative Hospitalization Stage
| Study group | Role | What they receive |
|---|---|---|
| Medical Humanities-based Patient Education Strategy | Active comparator | Mental Enhanced Education Strategy
Patients allocated to the enhanced mental health education intervention cohort will receive supplemental medical humanities modules alongside the standard Practical Education Strategy during hospitalization. This content is derived from a comic publication compiled by the breast surgery team of Fudan University Shanghai Cancer Center, which narrates the 4600-year human battle against breast cancer in a grand story. The content combines humorous cartoons with novel-like text, covering the evolution of human understanding of breast cancer, and the emergence and development of various therapies, drugs, and technologies. For patients unable to read, audio books and dynamic cartoon videos are available on mobile devices. The general content framework is as follows:
* Understanding of breast cancer in ancient Egypt and Persia;
* Hippocratic-Galenic Theories: early management of breast disorders in Greco-Roman antiquity;
* Traditional Chinese medical interpret Receives: Other: Medical Humanities-based Patient Education Strategy |
| Routine Patient Education Strategy | No intervention | Practical Education Strategy Admission Day * Comprehensive admission nursing assessment and introduction to care protocols: Admission assessment form, nutritional assessment, fall risk assessment, deep vein thrombosis risk assessment, pain assessment, etc. * Orientation to ward environment and policies: introduction to the medical team, online doctor-patient communication platform, ward facilities, daily routines, dietary guidelines, and other essential services, etc. * Review of medical history and guidance on preoperative examinations and precautions: Hematological tests, electrocardiogram, ultrasound, mammography, CT, MRI, core needle biopsy, fine needle aspiration, etc. Days Before Surgery * Personal preparation instructions: Bathing, hair washing, fasting, and fluid restriction guidelines, etc. * Interpretation of preoperative examination results. * Overview of common surgical approaches for breast cancer, introduction of surgery options based on the condition, especially emphasis on |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Five days after surgery
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.
Measured: Five days after surgery
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.
Measured: Five days after surgery
Secondary outcomes (9)
The proportion of patients opting for breast-conserving cosmetic procedures
including breast-conserving surgery, oncoplastic breast-conserving surgery, implant-based or autologous breast reconstruction
Measured: Five days after surgery
Incidence of postoperative complications requiring surgical intervention
Incidence of postoperative complications requiring surgical intervention within 12 months after surgery
Measured: 12 months follow-up
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.
Measured: 12 months follow-up
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).
Measured: 12 months follow-up
Quality of life assessment at discharge
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)
Measured: Five days after surgery
Quality of life assessment
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)
Measured: 12 months follow-up
Loss to follow-up rate
Loss to follow-up rate between study groups at 12-month follow-up
Measured: 12 months follow-up
Quality of life assessment
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)
Measured: 12 months follow-up
Quality of life assessment at discharge
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)
Measured: Five days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965556
- Sponsor's protocol ID
- PE-CAT
- Acronym
- PE-CAT
- Status last verified
- May 2025
- First submitted
- 16 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06965556
- Acronym / sponsor ID
- PE-CAT / PE-CAT
- Keywords
- breast carcinoma, patient education, educational comic, psychological intervention, hospitalization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,138 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Humanities-based Patient Education Strategy | Active comparator | Other: Medical Humanities-based Patient Education StrategyMental Enhanced Education Strategy Patients allocated to the enhanced mental health education intervention cohort will receive supplemental medical humanities modules alongside the standard Practical Education Strategy during hospitalization. This content is derived from a comic publication compiled by the breast surgery team of Fudan University Shanghai Cancer Center, which narrates the 4600-year human battle against breast cancer in a grand story. The content combines humorous cartoons with novel-like text, covering the evolution of human understanding of breast cancer, and the emergence and development of various therapies, drugs, and technologies. For patients unable to read, audio books and dynamic cartoon videos are available on mobile devices. The general content framework is as follows: * Understanding of breast cancer in ancient Egypt and Persia; * Hippocratic-Galenic Theories: early management of breast disorders in Greco-Roman antiquity; * Traditional Chinese medical interpret |
| Routine Patient Education Strategy | No intervention | –Practical Education Strategy Admission Day * Comprehensive admission nursing assessment and introduction to care protocols: Admission assessment form, nutritional assessment, fall risk assessment, deep vein thrombosis risk assessment, pain assessment, etc. * Orientation to ward environment and policies: introduction to the medical team, online doctor-patient communication platform, ward facilities, daily routines, dietary guidelines, and other essential services, etc. * Review of medical history and guidance on preoperative examinations and precautions: Hematological tests, electrocardiogram, ultrasound, mammography, CT, MRI, core needle biopsy, fine needle aspiration, etc. Days Before Surgery * Personal preparation instructions: Bathing, hair washing, fasting, and fluid restriction guidelines, etc. * Interpretation of preoperative examination results. * Overview of common surgical approaches for breast cancer, introduction of surgery options based on the condition, especially emphasis on |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Humanities-based Patient Education StrategyMedical Humanities-based Patient Education with Comic-based Medical Education Materials for Breast Cancer Patients during Perioperative Hospitalization Stage | Other | Medical Humanities-based Patient Education Strategy |
Primary outcome
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
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.
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Humanities-based Patient Education Strategy in people with Breast Carcinoma and Patient Education, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajian Chen, MD (862164175590, elwin1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety status at hospital discharge (time frame: Five days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.