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Using patient-reported outcomes(PRO) to manage postoperative symptoms in patients with breast cancer: a ragmatic randomised controlled trial

A study for perioperative symptom management in patients with breast cancer based on patient-reported outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064443
Enrollment
Unknown
Registered
2022-10-08
Start date
2022-10-10
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

PRO-based care group:PRO-based symptom management measures
Usual care group:Usual symptom management measures

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years. 2. Gender: female. 3. Clinical diagnosis of primary breast cancer stage I-IIIA (according to the 8th edition of the AJCC Cancer Staging Manual). 4. No distant organ metastases from the tumor. 5. Willing and able to complete the electronic questionnaire on a smartphone or tablet. 6. Sign the informed consent file.

Exclusion criteria

Exclusion criteria: 1. Complicated with other malignant tumors; 2. Combined with upper limb disability; 3. Previous history of chest surgery; 4. Complicated with cardiogenic, nephrogenic or dystrophic edema; 5. Contraindications for surgery: (1) Systemic contraindications: 1) Elderly and infirm patients who cannot tolerate surgery; 2) Poor general condition, showing bad liquid quality; 3) Patients with dysfunction of important organs who cannot tolerate surgery; (2) Contraindications for local lesions: Stage III patients with one of the following conditions: 1) Orange peel edema of breast skin exceeds half of breast area; 2) Satellite nodules appear in the breast skin; 3) Inflammatory breast cancer; 6. Pregnancy or lactation; 7. Long-term use of analgesic, anti-anxiety and antidepressant drugs; 8. Complicated with diabetes mellitus, immune disorders or severe liver disease; 9. Severe intellectual disability, mental illness, or cognitive impairment.

Design outcomes

Primary

MeasureTime frame
Patient's MDASI-C symptom assessment score on the day of discharge;

Secondary

MeasureTime frame
Number of threshold symptom events on the day the patient was discharged from the hospital;Trajectory of symptom intensity;Re-visit rate for surgical problems;

Countries

China

Contacts

Public ContactZhang Shuqun

Xi'an Jiaotong University Second Affiliated Hospital

shuqun_zhang1971@163.com+86 13891841249

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026