Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy

Официальное название

The Effect of Perioperative Rehabilitation Programme Delivered Via a Smart Phone Based Digital Platform in Patients Undergoing Neoadjuvant Therapy for Gastric Cancer Surgery: Study Protocol for a Randomised Controlled Trial

Обзор

The goal of this clinical trial is to investigate the effects of a perioperative multimodal rehabilitation program on the incidence of postoperative complications and perioperative clinical indexes including functional capacity, nutritional and psychological status in patients with gastric cancer undergoing neoadjuvant therapy. Besides the investigators also develop a smart phone based digital platform aiming to evaluate its effectiveness in improving patient adherence, compared with the conventional telephone supervision approach. The main questions it aims to answer are: * Can the perioperative multimodal rehabilitation program reduce postoperative complications in patients with gastric cancer undergoing neoadjuvant therapy? * Can the smart phone based digital platform improve patients' adherence compared to traditional telephone supervision? * Can the perioperative multimodal rehabilitation program improve the perioperative clinical indicators of patients with gastric cancer undergoing neoadjuvant therapy, including functional capacity, nutritional status and psychological condition? The investigators will compare the perioperative multimodal rehabilitation program with the standard treatment alone to determine whether this program has the effects mentioned above. Participants will follow the perioperative multimodal rehabilitation program from neoadjuvant therapy through to four weeks after discharge.

Вмешательства

• Поведенческое perioperative multimodal rehabilitation program with telephone supervision
  The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by st
• Процедура Usual Care
  Patients receive usual care throughout their cancer pathway. Besides, we will provide verbal exercise, dietary, and psychological advice to patients but did not provide written advice and supervision.
• Поведенческое perioperative multimodal rehabilitation program with digital supervision
  The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by st

Первичные конечные точки

• Complications at 90 days after surgery [Срок оценки: From the time of the surgery to 90 days postoperatively]

Вторичные конечные точки (12)

• Adherence--(1)Assessment completion rate [Срок оценки: From enrollment to 4 weeks after discharge]
• Adherence--(2)The mean number of training sessions attended [Срок оценки: From enrollment to 4 weeks after discharge]
• Adherence--(3)The number of patients requiring exercise intensity adjustment [Срок оценки: From enrollment to 4 weeks after discharge]
• Adherence--(4)The number of patients requiring early termination of the intervention [Срок оценки: From enrollment to 4 weeks after discharge]
• Adherence--(5)The number of patients who permanently discontinued the training [Срок оценки: From enrollment to 4 weeks after discharge]
• Adherence--(6)The number of patients lost to follow-up [Срок оценки: From enrollment to 4 weeks after discharge]
• Short-term safety--(1)Incidence of adverse events during the study [Срок оценки: From enrollment to 4 weeks after discharge]
• Short-term safety--(2) Postoperative in-hospital mortality rate [Срок оценки: From date of surgery until date of hospital discharge, assessed up to 2 weeks]
• Short-term safety--(3) 90-day postoperative mortality rate [Срок оценки: From the time of surgery to 90-day postoperative]
• Short-term safety--(4)Postoperative in-hospital morbidity rate [Срок оценки: From date of surgery until date of hospital discharge, assessed up to 2 weeks]
• Short-term safety--(5) 30-day postoperative morbidity rate [Срок оценки: From the time of surgery to 30-day postoperative]
• Short-term safety--(6) Morbidity rate during neoadjuvant therapy [Срок оценки: From start of neoadjuvant treatment to end of neoadjuvant treatment, assessed up to 100 days]

Критерии участия

Критерии включения

• patients aged between 18 and 70 years;
• patients with histologically confirmed resectable adenocarcinoma of the oesophago gastric junction or stomach;
• patients referred by a multidisciplinary team (MDT) for neoadjuvant therapy;
• patients able to use a smartphone and the digital follow up platform, and willing to comply with regular follow up assessments;
• patients who provide written informed consent.

Критерии исключения

• presence of distant metastasis;
• severe cardiopulmonary disease or other contraindications precluding completion of the 6MWT or participation in exercise training;
• concurrent other malignant tumours;
• suspected recurrent gastric cancer;
• cognitive impairment, communication barriers, or psychiatric conditions that would prevent compliance with the study procedures;
• women who are pregnant, lactating, or planning a pregnancy.

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

Лечение

Центры проведения

Китай · 1 центр

• Beijing Friendship Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07441850 · 2026-P2-011-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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