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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• 90-Day Postoperative Complication Rate After Esophagectomy [Срок оценки: Postoperative days 7, 14, 30, 60, and 90, complications will be assessed and recorded at each time point.]

Вторичные конечные точки (2)

• 90-Day Postoperative Mortality [Срок оценки: Postoperative days 30, 60, and 90, death events will be recorded, and causes of death will be analyzed.]
• Number of Symptom-Threshold Events [Срок оценки: 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.]

Критерии участия

Критерии включения

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

Критерии исключения

• Human immunodeficiency virus (HIV) infection.
• Psychiatric disorder.
• 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).
• Patient ultimately did not undergo curative (radical) surgical resection.
• 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).
• Difficulty in communication or inability to comply with long-term follow-up.
• Any other condition deemed unsuitable by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07211009 · ESO-PROSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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