Evaluation of a Combined PGHD-AI Intelligent Model for the Nutritional Assessment and Intervention of Patients After Radical Surgery for Pancreatic Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence and/or improvement rate
研究概览
简要总结
This study will collect patient PRO (physical strength, pain, defecation, appetite, weight, etc.) data through the APP, use corpus collection cards, facial photography and other technologies to collect PGHD characteristic phenotypes, and then combine artificial intelligence technology to train and cultivate agents (agents) to carry out joint offline routine follow-up of patients after radical pancreatic cancer resection to evaluate the feasibility of nutritional risk assessment intervention. Thus, the feasibility of artificial intelligence prediction of health status is verified, and an efficient follow-up tool and nutritional support evaluation plan are provided for the management of pancreatic cancer patients throughout the course of the disease, so as to improve the treatment prognosis and quality of life of pancreatic cancer patients.
详细描述
This study is a prospective randomized controlled exploratory clinical trial to recruit 200 patients after radical pancreatic cancer resection.
Screening eligible subjects will be randomly assigned to the test group and the control group, and the randomization stratification factors include: age, gender, TNM stage, ECOG score, baseline BMI.
The experimental group and the control group received offline routine follow-up combined with PGHD-AI's APP management and routine outpatient follow-up, respectively, to compare the prediction of nutritional status risk and intervention response.
The study period is 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old, and voluntarily signed the informed consent form to participate in the study;
- •Meet the clinical and pathological diagnostic criteria for pancreatic cancer (ICD-10:C25);
- •After radical surgery, fully recovered from surgery at randomization;
- •ECOG PS score 0-1 ;
- •Have objective conditions to complete follow-up and examination during the study process.
排除标准
- •Patients or their families are willing to use the APP;
- •Current history or past history of metastatic or locally recurrent pancreatic cancer;
- •Combined with other serious organ dysfunctions (such as severe liver and kidney insufficiency, heart failure, etc.);
- •Women who are currently pregnant or lactating;
- •History of other tumor diseases in the past;
- •Other conditions that the study deems unsuitable for participation in the study, including but not limited to: patients with serious or uncontrollable medical conditions, safety risks, interference with the interpretation of study results, and impact on study compliance.
研究组 & 干预措施
Intervention group
Patients use the APP to check in daily and record PGHD data, combined with offline routine follow-up, nutritional assessment and intervention.
干预措施: PGHD's AI intelligent model(APP) (Other)
Control group
Patients received routine outpatient follow-up and nutritional assessment by investigator.
结局指标
主要结局
The incidence and/or improvement rate
时间窗: 12 months after enrollment
The overall survival time
时间窗: 12 months after enrollment
The progression free survival
时间窗: 12 months after enrollment
次要结局
未报告次要终点
研究者
Jiang Long
Head of pancreatic surgery
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine