NCT07441850招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Complications at 90 days after surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Complications at 90 days after surgery
时间窗: From the time of the surgery to 90 days postoperatively
The primary outcome of the study is the postoperative morbidity rate by the Clavien-Dindo classification at 90 days postoperatively. All postoperative complications will be documented at discharge and the surgeon will record any events after discharge at the outpatient appointment 90 days postoperatively. All complications will be classified by the Clavien-Dindo classification.
次要结局
- Nutritional status--(6)Hemoglobin level(From enrollment to 1 year postoperatively)
- Short-term safety--(1)Incidence of adverse events during the study(From enrollment to 4 weeks after discharge)
- Nutritional status--(7)Prealbumin level(From enrollment to 1 year postoperatively)
- Nutritional status--(8)Total cholesterol level(From enrollment to 1 year postoperatively)
- Short-term safety--(2) Postoperative in-hospital mortality rate(From date of surgery until date of hospital discharge, assessed up to 2 weeks)
- Short-term safety--(3) 90-day postoperative mortality rate(From the time of surgery to 90-day postoperative)
- Short-term safety--(4)Postoperative in-hospital morbidity rate(From date of surgery until date of hospital discharge, assessed up to 2 weeks)
- Short-term safety--(5) 30-day postoperative morbidity rate(From the time of surgery to 30-day postoperative)
- Adherence--(4)The number of patients requiring early termination of the intervention(From enrollment to 4 weeks after discharge)
- Adherence--(5)The number of patients who permanently discontinued the training(From enrollment to 4 weeks after discharge)
- Adherence--(1)Assessment completion rate(From enrollment to 4 weeks after discharge)
- Adherence--(2)The mean number of training sessions attended(From enrollment to 4 weeks after discharge)
- Adherence--(3)The number of patients requiring exercise intensity adjustment(From enrollment to 4 weeks after discharge)
- Adherence--(6)The number of patients lost to follow-up(From enrollment to 4 weeks after discharge)
- Short-term safety--(6) Morbidity rate during neoadjuvant therapy(From start of neoadjuvant treatment to end of neoadjuvant treatment, assessed up to 100 days)
- The quality of life--(1) EORTC-QLQ-C30(From enrollment to 1 year postoperatively)
- The quality of life--(2) EORTC-QLQ-STO22(From enrollment to 1 year postoperatively)
- The quality of life--(3)PGSAS-45(From the time of surgery to 1 year postoperatively)
- Functional capacity--(1) The sit to stand test(From enrollment to 1 year postoperatively)
- Functional capacity--(2) The handgrip strength(From enrollment to 1 year postoperatively)
- Functional capacity--(3) Peak oxygen consumption (VO₂ peak)(From enrollment to 1 year postoperatively)
- Functional capacity--(4) anaerobic threshold (AT)(From enrollment to 1 year postoperatively)
- Functional capacity--(5) 6-minute walk test(6MWT)(From enrollment to 1 year postoperatively)
- Functional capacity--(6) Frailty(From enrollment to 1 year postoperatively)
- Nutritional status--(1) BMI(From enrollment to 1 year postoperatively)
- Nutritional status--(2)skeletal muscle index(SMI)(From enrollment to 1 year postoperatively)
- Nutritional status--(3)mid-upper arm circumference(MUAC)(From enrollment to 1 year postoperatively)
- Nutritional status--(4)triceps skinfold thickness(TSF)(From enrollment to 1 year postoperatively)
- Nutritional status--(5)insulin resistance(IR)(From enrollment to 1 year postoperatively)
- Nutritional status--(9)Serum albumin level(From enrollment to 1 year postoperatively)
- Nutritional status--(10)Total lymphocyte count(From enrollment to 1 year postoperatively)
- Nutritional status--(11)Inflammatory marker(From enrollment to 1 year postoperatively)
- Nutritional status--(12)Glasgow Prognostic Score (GPS)(From enrollment to 1 year postoperatively)
- Nutritional status--(13)prognostic nutritional index(PNI)(From enrollment to 1 year postoperatively)
- Psychological scale scores--(1)Hospital Anxiety and Depression Scale (HADS)(From enrollment to 1 year postoperatively)
- Psychological scale scores--(2)Life Orientation Test Revised (LOT-R)(From enrollment to 1 year postoperatively)
- Psychological scale scores--(3)General Self Efficacy Scale (GSE)(From enrollment to 1 year postoperatively)
- Psychological scale scores--(4)EuroQol 5 Dimension 5 Level (EQ-5D-5L)(From enrollment to 1 year postoperatively)
- Psychological scale scores--(5)Pearlin Mastery Scale (PMS)(From enrollment to 1 year postoperatively)
- Psychological scale scores--(6)Surgical Fear Questionnaire (SFQ)(From enrollment to the day before surgery, assessed up to 100 days)
- Gastric emptying function(From the time of surgery to 90-day postoperative)
研究者
JunZhang
Chief Surgeon
Beijing Friendship Hospital
研究点 (1)
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