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| Name | Class |
|---|---|
| Linyi People's Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
| Yantai Yuhuangding Hospital | OTHER |
| Central Hospital of Zibo |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with early structured postoperative intervention | Experimental |
| |
| Patients without early structured postoperative intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early structured postoperative intervention encompassing nutrition, psychology, and exercise | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline (Day of Discharge) and POD 30（30 days after surgery） |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28076708 | Background | Basch E. Patient-Reported Outcomes - Harnessing Patients' Voices to Improve Clinical Care. N Engl J Med. 2017 Jan 12;376(2):105-108. doi: 10.1056/NEJMp1611252. No abstract available. | |
| 35012741 | Background | Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7. |
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All individual participant data (IPD) underlying the published results
Beginning 6 months and ending 36 months following publication
Data will be made available to researchers who provide a methodologically sound proposal, subject to approval by an independent review committee and execution of a data use agreement.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011584 | Psychology |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D009043 | Motor Activity |
| D009068 | Movement |
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| OTHER |
| Weifang People's Hospital | OTHER |
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|
| 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. | 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. | 6 month after surgery |
| Grading of chemotherapy-related adverse events | It was evaluated by CTCAE version 5.0，with severity classified from Grade 1 (mild) to Grade 5 (death). | 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. | Baseline (Day of Discharge) and POD 30（30 days after surgery） |
| 34665392 | Background | Michard F, Thiele RH, Le Guen M. One small wearable, one giant leap for patient safety? J Clin Monit Comput. 2022 Feb;36(1):1-4. doi: 10.1007/s10877-021-00767-0. Epub 2021 Oct 19. No abstract available. |
| 33856385 | Background | Tian Y, Cao S, Liu X, Li L, He Q, Jiang L, Wang X, Chu X, Wang H, Xia L, Ding Y, Mao W, Hui X, Shi Y, Zhang H, Niu Z, Li Z, Jiang H, Kehlet H, Zhou Y. Randomized Controlled Trial Comparing the Short-term Outcomes of Enhanced Recovery After Surgery and Conventional Care in Laparoscopic Distal Gastrectomy (GISSG1901). Ann Surg. 2022 Jan 1;275(1):e15-e21. doi: 10.1097/SLA.0000000000004908. |
| 38888922 | Background | Sauro KM, Smith C, Ibadin S, Thomas A, Ganshorn H, Bakunda L, Bajgain B, Bisch SP, Nelson G. Enhanced Recovery After Surgery Guidelines and Hospital Length of Stay, Readmission, Complications, and Mortality: A Meta-Analysis of Randomized Clinical Trials. JAMA Netw Open. 2024 Jun 3;7(6):e2417310. doi: 10.1001/jamanetworkopen.2024.17310. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |