The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Rate of the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty)
研究概览
简要总结
- Research methods Constructed the "Manual for Graded Management of Postoperative Symptoms of Esophageal Cancer" and developed continuous care Procedures.
- Randomised controlled studies were conducted to verify the effects of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is aware and able to communicate in Mandarin;
- •There are smartphones；
- •Proficient in using WeChat mini programs.
- •Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.
排除标准
- •Have cognitive impairment or psychiatric illness;
- •Refusal to participate
研究组 & 干预措施
Group 1：Smart Symptom Management Program
During the first six months after surgery, patients in the experimental group will use a WeChat mini-program to proactively self-report their symptoms regularly using the Chinese version of the MD Anderson Symptom Inventory for Esophageal Cancer (MDASI-EC). Based on the reported scores and the pre-defined algorithms in the "Post-Esophagectomy Symptom Grading Management Manual", the system will automatically provide personalized self-management guidance for low-grade symptoms. For more severe symptoms, the system will generate alerts to prompt dedicated study nurses to initiate proactive telephone follow-up and provide tailored health coaching.
干预措施: Smart Symptom Management Program (Device)
Group 2：Routine Care
Patients in the control group will receive standard post-discharge care as per hospital protocol, which includes routine discharge education and instructions to contact the hospital if problems arise. They will not use the WeChat mini-program and will not receive proactive symptom monitoring or coaching calls.
结局指标
主要结局
Rate of the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty)
时间窗: 12 weeks after surgery
Primary outcome was the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty) rated ≥4 on the MDASI-EC at 12 weeks after surgery. This composite endpoint was selected based on our prior symptom trajectory studies, as these three symptoms are the most common and most distressing after esophagectomy.
Rate of Major Postoperative Complications
时间窗: From the date of surgery until postoperative day 42 (6 weeks).
The proportion of patients experiencing one or more postoperative complications with a Clavien-Dindo classification of Grade II or higher. Complications will be identified and graded by reviewing patient electronic medical records and discharge summaries. The outcome will be reported as a binary variable (yes/no), and the rate (percentage) will be calculated for each group.
30-Day All-Cause Readmission Rate
时间窗: From the date of hospital discharge until 30 days post-discharge.
The proportion of patients readmitted to the hospital for any cause within 30 days of discharge. Data will be confirmed via hospital information system (HIS) records. The outcome will be reported as a percentage.
Mean Score of Symptom Severity Items on the MD Anderson Symptom Inventory (MDASI) Module for Esophageal Cancer
时间窗: Assessed at baseline (preoperatively), and then at 1 month, 3 months, and 6 months postoperatively
Symptom severity will be assessed using the symptom severity subscale of the validated MD Anderson Symptom Inventory (MDASI) module for esophageal cancer. This subscale includes 13 core cancer-related symptoms. Patients will rate the severity of each symptom over the last 24 hours on a numeric scale from 0 ("not present") to 10 ("as bad as you can imagine"). The outcome value for each participant at each time point will be the mean score of these 13 symptom severity items. A higher mean score indicates a greater symptom burden.
Mean Score of Symptom Interference Items on the MD Anderson Symptom Inventory (MDASI) Module for Esophageal Cancer
时间窗: Assessed at baseline (preoperatively), and then at 1 month, 3 months, and 6 months postoperatively
The impact of symptoms on daily life will be assessed using the symptom interference subscale of the validated MD Anderson Symptom Inventory (MDASI) module for esophageal cancer. This subscale evaluates how symptoms have interfered with 6 different aspects of daily life (e.g., general activity, mood, work) over the last 24 hours. Ratings are on a numeric scale from 0 ("did not interfere") to 10 ("completely interfered"). The outcome value for each participant at each time point will be the mean score of these 6 symptom interference items. A higher mean score indicates a greater negative impact on daily life.
次要结局
- the proportion of patients with a score ≥4 for each individual symptom items(12 weeks after surgery)
- composite functional interference scores: WAW (the average of walking, general activity, work) and REM (the average of relations with others, mood, enjoyment of life)(12 weeks after surgery)
- 30-day unplanned hospital readmission rate (including emergency department visits or unscheduled outpatient visits).(30 days after surgery)