The Impact of Multimodal Digital Fusion AI-Assisted Decision Support System-Based Comprehensive Management on Clinical Outcomes in County-Level Patients With Comorbid Cancer:A Prospective Non-randomized Controlled Interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Combined with the digital whole process management data pool, a multi-modal data fusion framework is developed, and an AI model is established to realize risk stratification and personalized treatment Recommendation and dynamic prognosis prediction; validation of whole-process management based on multimodal digital fusion AI-aided decision support system through prospective non-randomized controlled interventional study The effect on survival, complication control and utilization of medical resources in patients with comorbid malignant tumors.
详细描述
The title of this study is"The Impact of Multimodal Digital Fusion AI-Assisted Decision Support System-Based Comprehensive Management on Clinical Outcomes in County-Level Patients with Comorbid Cancer: A prospective non-randomized controlled interventional study", to evaluate the impact of full-course management based on a multimodal digital fusion AI-assisted decision support system on the clinical outcomes of county-level oncologic comorbid patients through a prospective non-randomized controlled interventional study. The study plans to enroll 5,000 patients with pathologically confirmed malignancies and at least one comorbid condition (diabetes, hypertension, etc.) , in the first stage, the epidemiological characteristics of co-morbidity and its impact on prognosis, treatment response and quality of life were analyzed In the second phase, patients with comorbid pulmonary malignancies were selected to compare the clinical effects of the voluntary whole-process management group (including personalized intervention such as nutritional screening and dynamic monitoring) and the conventional treatment group, the third stage integrates multi-center Electronic Medical Records, genomic data, wearable device monitoring and other multi-modal data to construct an AI decision-making system, developing risk stratification, personalized treatment recommendation, and dynamic prognostic prediction models, finally, the differences in core indicators such as survival rate (PFS, OS) , complication control and medical resource efficiency between AI-assisted management and traditional mode were compared. This study realizes the integrated intervention of in-hospital and out-of-hospital through digital whole-process management, which is expected to provide an AI-driven precise decision support paradigm for primary medical institutions and improve the efficiency of comprehensive management of tumor comorbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a definite diagnosis of malignancy by histopathology and/or cytology;
- •Age ≥18 years;
- •There is no gender limit
- •Plan to receive antineoplastic therapy within 2 weeks or are receiving standard antineoplastic care (surgery, radiation, chemotherapy, or targeted therapy) ;
- •Conscious and able to answer questions and use electronic devices autonomously;
- •Patients were able to understand the study and voluntarily sign an informed consent form;
排除标准
- •Having severe mental or cognitive impairments that prevent them from understanding the content of the study or implementing the programme;
- •With severe heart disease, acute respiratory failure, liver kidney failure and other critical illness;
- •Women during pregnancy or lactation；
- •Have participated in other interventional studies in the past 1 month or are currently participating;
- •Patients with ECOG ≥ 3 that do not respond to treatment;
- •Patients with an expected survival of < 3 months that do not respond to treatment;
- •Cases deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
AI management unit
For patients with comorbid pulmonary malignancies who have been included, the registration process is guided by the management platform. Researchers will use digital management throughout The platform carries out screening assessment and Comprehensive Evaluation of nutrition, exercise, psychology and symptoms of the subjects, and the system will be combined with the patient's disease and treatment Information, intelligent management of the whole project. The clinician can review the protocol in the light of the patient's disease status and give the full management instructions Case to patient side.
干预措施: AI-assisted comprehensive management system (Other)
Standard Clinical Management
Patients who are not willing to accept the whole program will only be followed up, and will receive standard clinical management without AI-assisted digital platform support. Patients will receive conventional treatment. In the data analysis phase, subjects were stratified to explore the feasibility and effectiveness of digital whole-course management in patients with oncological comorbidities.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 24 months
Progression-free survival (PFS) : the time from randomization (or study enrollment) to the observation of disease progression or the occurrence of death from any cause. This period was assessed every 6-8 weeks using RECIST 1.1 criteria.
Overall survival (OS）
时间窗: 24 months
Overall survival (OS） : the time from study enrollment to death from any cause from any cause, every 3 months during treatment, and every 3 months after the end of treatment. The patients were followed up at 6 months and the cause of death was recorded.
次要结局
- Comorbidity control rate.(24 months)
- Quality of life(QLQ-C30).(24 months)
- Medical resource consumption index.(24 months)
- Adherence to AI system interventions.(24 months)