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

NCT07211009 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-10-07

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer (EsC)

Interventions

OTHER

Patient-Reported Outcome (PRO)-Based Symptom Management

Postoperative esophageal cancer patients will receive a PRO (patient-reported outcome) symptom self-report system via a WeChat mini-program/electronic form. The system covers 12 target symptoms-pain, fever, cough with sputum, dyspnea, palpitations, fatigue and activity limitation, nausea/vomiting, acid reflux/heartburn, abdominal bloating, diarrhea, swallowing obstruction (dysphagia), and hoarseness with coughing when drinking-and uses a five-level severity scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe). If any of the 12 symptom scores entered in the mini-program reaches the predefined intervention threshold (≥2, indicating moderate to very severe), the system sends a real-time alert to the surgeon, who is required to respond within a specified time window. After discharge, interventions are delivered via WeChat, text message, or telephone. Interventions mainly include counseling, patient education, prescription medication.

OTHER

Conventional Management

Patients in the control arm receive conventional postoperative symptom management. The electronic questionnaires use the same content and time points as the intervention arm, but reported symptoms do not trigger alerts, and surgeons cannot view the symptom scores. During the postoperative inpatient stay, surgeons typically assess symptom severity based on patient reports during morning and afternoon rounds and manage symptoms according to the same guidelines and consensus as the intervention arm. After discharge, patients do not receive proactive symptom management from their primary surgeon unless they actively seek medical care.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2028-06-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211009 on ClinicalTrials.gov