Early Postoperative Structured Intervention for Quality of Life and Prognosis in Gastric Cancer Patients After Neoadjuvant Therapy：: A Multicenter,Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- incidence of complications within 30 days postoperatively
研究概览
简要总结
This study was conducted by Qilu Hospital and five other renowned medical centers, aiming to evaluate the impact of early structured postoperative intervention on quality of life and prognosis in patients with gastric cancer after neoadjuvant therapy.
详细描述
Investigators are conducting a two-arm, multicenter, interventional study at Qilu Hospital of Shandong University and five other renowned hospitals in China. A total of 264 gastric cancer patients who have completed preoperative neoadjuvant therapy will be randomly assigned to either the control group or the experimental group.For control group,patients will receive standard ERAS discharge management, including routine discharge education; outpatient follow-up visits on postoperative day 7 and postoperative day 30; and emergency contact via hospital telephone or emergency department visits for urgent situations.For experimental group,in addition to standard ERAS discharge management, patients will receive multimodal structured interventions during follow-up visits targeting nutritional status, psychological status, and exercise status. Nutritional intervention: Routine postoperative oral nutritional supplements (ONS) will be provided, and patients with metabolic diseases such as diabetes will undergo strict glycemic control. Psychological intervention: Patients with a Hospital Anxiety and Depression Scale (HADS) score ≥ 8 will receive cognitive behavioral therapy (CBT), and those with a HADS score ≥ 11 will be referred for psychological consultation. Exercise intervention: Postoperative rehabilitation training will be guided according to different postoperative periods.During the study period, the incidence of complications within 30 days postoperatively and quality of postoperative recovery were statistically analyzed, among other outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years;
- •Histologically confirmed adenocarcinoma by preoperative pathology;
- •Completed preoperative neoadjuvant therapy without obvious immune-related adverse events (irAEs);
- •Patients with ycT3-4N+Mx disease deemed surgically resectable based on evaluation by gastroscopy, CT, PET-CT, and other imaging modalities;
- •Signed informed consent and voluntary participation in this study;
- •Standard ERAS (Enhanced Recovery After Surgery) management during the - perioperative period, with postoperative hospital stay ≤7 days.
排除标准
- •Patients with central nervous system diseases or psychiatric disorders;
- •Patients with severe diseases of other organ systems;
- •Patients with recurrent infectious diseases or severe comorbidities;
- •Patients requiring synchronous surgery for other diseases;
- •Patients undergoing emergency surgery;
- •Patients who developed any complication during hospitalization.
研究组 & 干预措施
Patients with early structured postoperative intervention
干预措施: Early structured postoperative intervention encompassing nutrition, psychology, and exercise (Combination Product)
Patients without early structured postoperative intervention
结局指标
主要结局
incidence of complications within 30 days postoperatively
时间窗: 30 days after operation
The incidence of complications within 30 days postoperatively was calculated as the number of patients who developed complications within 30 days after surgery divided by the total number of patients in that group.
Postoperative recovery quality
时间窗: Baseline (Day of Discharge) and POD 30（30 days after surgery）
Postoperative recovery quality was assessed using The 15-item Quality of Recovery Score scale, with a maximum score of 150 points and a minimum score of 0 points, where higher scores indicate better postoperative recovery quality
次要结局
- Grading of chemotherapy-related adverse events(6 month after surgery)
- Readmission or emergency department visit rate within 30 days postoperatively(30 days after surgery)
- Time interval between surgery and initiation of adjuvant chemotherapy(6 month after surgery)
- Completion rate of postoperative chemotherapy / Adherence to adjuvant chemotherapy(6 month after surgery)
- Postoperative quality of life score(Baseline (Day of Discharge) and POD 30（30 days after surgery）)
研究者
Qu Hui
Chief Physician
Qilu Hospital of Shandong University