A Single-Center, Randomized, Controlled, Phase III Clinical Study of Patient-Reported Outcome-Based Symptom Management Versus Conventional Management in Postoperative Esophageal Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- 90-Day Postoperative Complication Rate After Esophagectomy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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) ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
PRO Symptom Management Group
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.
干预措施: Patient-Reported Outcome (PRO)-Based Symptom Management (Other)
Conventional Management Group
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.
干预措施: Conventional Management (Other)
结局指标
主要结局
90-Day Postoperative Complication Rate After Esophagectomy
时间窗: 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.
次要结局
- 90-Day Postoperative Mortality(Postoperative days 30, 60, and 90, death events will be recorded, and causes of death will be analyzed.)
- 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.)
研究者
Zhen-Yu Ding
Professor
Sichuan University