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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
264
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.
Qilu Hospital of Shandong University
Jinan, Shandong, China
incidence of complications within 30 days postoperatively
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.
Time frame: 30 days after operation
Postoperative recovery quality
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
Time frame: Baseline (Day of Discharge) and POD 30（30 days after surgery）
Readmission or emergency department visit rate within 30 days postoperatively
The rate of Readmission or emergency department visit within 30 days postoperatively was calculated as the number of patients who was readmitted or visited emergency department within 30 days after surgery divided by the total number of patients in that group.
Time frame: 30 days after surgery
Time interval between surgery and initiation of adjuvant chemotherapy
The time interval was calculated as the number of days from postoperative day 1 to the start of adjuvant chemotherapy.
Time frame: 6 month after surgery
Completion rate of postoperative chemotherapy / Adherence to adjuvant chemotherapy
The completion rate of postoperative chemotherapy was calculated as the number of chemotherapy cycles actually completed divided by the number of chemotherapy cycles planned.
Time frame: 6 month after surgery
Grading of chemotherapy-related adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
It was evaluated by CTCAE version 5.0，with severity classified from Grade 1 (mild) to Grade 5 (death).
Time frame: 6 month after surgery
Postoperative quality of life score
The EORTC Quality of Life Questionnaire for Gastric Cancer (C30 + STO22) questionaire was used to evaluate quality of postoperative recovery, all scales range from 0 to 100. For global health status, higher scores indicate better outcomes; for all functioning and symptom scales in both questionnaires, higher scores indicate worse outcomes.
Time frame: Baseline (Day of Discharge) and POD 30（30 days after surgery）