Patient-Reported Symptom Care Versus Usual Care After Esophageal Cancer Surgery: A Single-Center Phase 3 Randomized Trial

Not Applicable

Not yet recruiting

• Conditions: Esophageal Cancer (EsC)

• Registration Number: NCT07211009
• Lead Sponsor: Sichuan University

Brief Summary

Symptom management is fundamental to clinical care, and symptom monitoring is an effective means to detect potential adverse events early and prevent serious complications. Extensive studies show that symptom management based on patient-reported outcomes (PROs) can reduce symptom burden, improve functional status and quality of life, lower emergency visits and readmissions, and even prolong survival. However, in the field of esophageal cancer surgery, prospective clinical studies assessing the feasibility of postoperative PRO-based symptom management remain lacking. This project proposes a randomized controlled trial (RCT) in China to systematically evaluate the effectiveness and feasibility of PRO-based symptom management after esophageal cancer surgery. Through this clinical study, we aim to assess both the impact and the implementability of introducing a proactive, patient-centered PRO symptom-management model into esophageal surgical care.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-10-15
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Age 18-75 years.
2. Pathologically confirmed esophageal cancer.
3. Planned to undergo curative (radical) surgical resection.
4. R0 resection.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
6. Adequate function of major organs.
7. Willing to complete questionnaire surveys.
8. Voluntarily agrees to participate and signs the informed consent form.
9. Good compliance and able to complete follow-up as scheduled.

Exclusion Criteria

1. Human immunodeficiency virus (HIV) infection.
2. Psychiatric disorder.
3. Any other malignancy within the past 5 years (except completely cured carcinoma in situ of the cervix or basal cell/squamous cell carcinoma of the skin).
4. Patient ultimately did not undergo curative (radical) surgical resection.
5. Any unstable systemic disease (including active, uncontrolled gastrointestinal ulcer; active infection; grade 4 hypertension; unstable angina; congestive heart failure; unstable cerebrovascular disease; thrombotic disease; hepatic, renal, or metabolic disease; or unhealed fracture/wound as determined by the surgeon).
6. Difficulty in communication or inability to comply with long-term follow-up.
7. Any other condition deemed unsuitable by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
90-Day Postoperative Complication Rate After Esophagectomy	Postoperative days 7, 14, 30, 60, and 90, complications will be assessed and recorded at each time point.	Proportion of patients who develop any surgery-related complication within 90 days after esophagectomy for esophageal cancer. Complication types and grades will follow the 2023 Chinese Expert Consensus on the Definition and Grading of Perioperative Complications in Esophageal and Esophagogastric Junction Cancer; complications are graded I-V, with higher grades indicating greater severity.

Secondary Outcome Measures

Name	Time	Method
90-Day Postoperative Mortality	Postoperative days 30, 60, and 90, death events will be recorded, and causes of death will be analyzed.	Postoperative mortality, including death from any cause.
Number of Symptom-Threshold Events	Assess each patient-reported symptom on the day of discharge and 1 day before discharge, and on postoperative days 30, 60, and 90, and record the score for each symptom.	Number of events in which any of the 12 target symptoms has a score ≥2.