Gastric Cancer (GC), Postoperative Recovery
Conditions
Keywords
gastric cancer, postoperative care, postoperative complications, recover quality
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTEarly structured postoperative intervention encompassing nutrition, psychology, and exercise
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.
Sponsors
Qilu Hospital of Shandong University
Linyi People's Hospital
Liaocheng People's Hospital
Yantai Yuhuangding Hospital
Central Hospital of Zibo
Weifang People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of complications within 30 days postoperatively | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission or emergency department visit rate within 30 days postoperatively | 30 days after surgery | 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 interval between surgery and initiation of adjuvant chemotherapy | 6 month after surgery | The time interval was calculated as the number of days from postoperative day 1 to the start of adjuvant chemotherapy. |
| Completion rate of postoperative chemotherapy / Adherence to adjuvant chemotherapy | 6 month after surgery | The completion rate of postoperative chemotherapy was calculated as the number of chemotherapy cycles actually completed divided by the number of chemotherapy cycles planned. |
| Grading of chemotherapy-related adverse events | 6 month after surgery | It was evaluated by CTCAE version 5.0，with severity classified from Grade 1 (mild) to Grade 5 (death). |
| Postoperative quality of life score | Baseline (Day of Discharge) and POD 30（30 days after surgery） | 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. |
Countries
China
Outcome results
None listed