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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO Symptom Management Group | Experimental | In the PRO arm, participants receive postoperative, PRO-based symptom management: when any target symptom score in the self-report system reaches or exceeds the predefined intervention threshold (≥2 points, indicating moderate to very severe), the system sends a real-time alert to the surgeon. The surgeon implements an intervention within the specified time window according to symptom severity. After discharge, follow-up and management are conducted via WeChat, text message, or telephone. All interventions are formulated based on relevant literature, guidelines, and expert consensus. |
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| Conventional Management Group | Active Comparator | In the control arm, participants 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 scores. During hospitalization, surgeons typically assess symptom severity based on patient reports during morning and afternoon rounds and manage care according to the same guidelines and consensus as the intervention arm. After discharge, no proactive symptom management is provided unless the patient actively seeks medical assistance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Reported Outcome (PRO)-Based Symptom Management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 90-Day Postoperative Complication Rate After Esophagectomy | 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. | Postoperative days 7, 14, 30, 60, and 90, complications will be assessed and recorded at each time point. |
| Measure | Description | Time Frame |
|---|---|---|
| 90-Day Postoperative Mortality | Postoperative mortality, including death from any cause. | Postoperative days 30, 60, and 90, death events will be recorded, and causes of death will be analyzed. |
| Number of Symptom-Threshold Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Conventional Management | Other | 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. |
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Number of events in which any of the 12 target symptoms has a score ≥2.
| 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. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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