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

A Single-Center, Randomized, Controlled, Phase III Clinical Study of Patient-Reported Outcome-Based Symptom Management Versus Conventional Management in Postoperative Esophageal Cancer Patients

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.

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.