Early Postoperative Intervention in Gastric Cancer Patients

Официальное название

Early Postoperative Structured Intervention for Quality of Life and Prognosis in Gastric Cancer Patients After Neoadjuvant Therapy：: A Multicenter,Open Label Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт Early 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 a

Первичные конечные точки

• incidence of complications within 30 days postoperatively [Срок оценки: 30 days after operation]
• Postoperative recovery quality [Срок оценки: Baseline (Day of Discharge) and POD 30（30 days after surgery）]

Вторичные конечные точки (5)

• Readmission or emergency department visit rate within 30 days postoperatively [Срок оценки: 30 days after surgery]
• Time interval between surgery and initiation of adjuvant chemotherapy [Срок оценки: 6 month after surgery]
• Completion rate of postoperative chemotherapy / Adherence to adjuvant chemotherapy [Срок оценки: 6 month after surgery]
• Grading of chemotherapy-related adverse events [Срок оценки: 6 month after surgery]
• Postoperative quality of life score [Срок оценки: Baseline (Day of Discharge) and POD 30（30 days after surgery）]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Публикации

• 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. PMID 28076708
• 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. PMID 35012741
• 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. PMID 34665392
• 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. PMID 33856385
• 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. PMID 38888922

Идентификаторы

NCT: NCT07444099 · KYLL-202501-049-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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