Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Daily collection of basis real world data such as physical activity in non-small-cell lung cancer patients by portable monitoring systems
研究概览
简要总结
The use of advanced technological tools able to exploit patient-centered "Real World Data", represents an innovative and fascinating challenge for the most modern personalized medicine paradigms.
Monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset and treatment outcomes prediction.
The big data approach, being able to collect, manage and interpret large volumes of health data, eventually supported by artificial intelligence (A.I.) is therefore fundamental in this setting and may be translated in the next future in tangible advantages for the patients.
Primary aim of the project is to assess patients experience of using portable monitoring systems during multimodal oncological therapies and follow up period, through the use of a dedicated app and wearable technology (i.e. monitoring bracelet), as Electronic Health Record data harvesting devices.
More specifically, the patients report experience measure of man/women affected by locally advanced non-small-cell lung cancer undergoing chemo(radio)therapy followed either by surgery or immunotehrapy (e.g. describing toxicity, instrumental activities of daily living and stress/coping levels) will be analyzed.
The machine learning assisted analysis of these data will allow to identify patients profile that may be used as risk categories to optimize assistance and follow up practices.
This is an observational study with device, co-financed, monocentric study with a foreseen study duration of 36 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged < 75
- •Clinically able to use portable technologies
- •Able to understand and sign informed consent
排除标准
- •Major psychiatric disorder
- •ECOG>2 performance status
- •Not able to use portable technologies
结局指标
主要结局
Daily collection of basis real world data such as physical activity in non-small-cell lung cancer patients by portable monitoring systems
时间窗: 8-52 weeks
Patients will receive a state-of -the-art wearable device (electronic wrist bracelet) that will collect real world data everyday such as physical activity that will be established on the basis of the number of steps per day. The device will be delivered to patients during the first appointment prior to the beginning of chemotherapy and/or radiotherapy. The collected data will be then transferred to the patient's paired device through the application Healthentia downloaded on appropriate instruments (e.g. smartphone). Data will be collected during multimodal oncological therapies and follow-up period.
Daily collection of basis real world data such as sleep habits in non-small-cell lung cancer patients by portable monitoring systems
时间窗: 8-52 weeks
Patients will receive a state-of -the-art wearable device (electronic wrist bracelet) that will collect real world data everyday such as sleep habits that will be established on the basis of the number of sleeping hours.
Daily collection of basis real world data such as vital signs in non-small-cell lung cancer patients by portable monitoring systems
时间窗: 8-52 weeks
Patients will receive a state-of -the-art wearable device (electronic wrist bracelet) that will collect real world data everyday such as vital signs that will be established on the basis of heartbeats per minute. A normal resting heart rate should be between 60 to 100 beats per minute.
次要结局
- The completion of the EORTC QLQ-C30 questionnaire(8-52 weeks)
- The completion of the Distress thermometer - DT6 test(8-52 weeks)
- The completion of Lawton Instrumental Activities of Daily Living questionnaire(8-52 weeks)
- The completion of the Malnutrition Screening Tool(8-52 weeks)
- The completion of Mental Adjustment to Cancer Scale - MINI-MAC 7 questionnaire(8-52 weeks)