Treatment and Prognosis Management Service for Cancer Patients Using AIoT(AI+IoT):Stomach Cancer,Colon Cancer, Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Change of body composition (weight, kg)
研究概览
简要总结
Recently, the use of mobile health is increasing for the purpose of managing prognosis such as recurrence, survival and quality of life by using a wearable smart band and a smartphone application. In the era of the 4th revolution, mobile health for the purpose of comprehensive prognosis for cancer patients is becoming a very good tool.
It is possible to confirm the clinical significance of short-term and temporary health care through a mobile application and a smart band during the treatment process for cancer patients, but the study is insufficient to generalize the number of subjects.
Therefore, for colon cancer patients who need prognosis management after surgery, we will investigate the effect of a mobile application using a smart band which has a modular structure reflecting the treatment method and treatment process after surgery.
This study targets patients who underwent prostate cancer surgery. An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for prostate cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months. Control group is provided general education through the hospital brochure. Evaluation will be conducted 2-3days after surgery (before discharge), and at 1, 3, 6, and 12 months after surgery.
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
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who have been diagnosed with colorectal cancer and have undergone surgery (not related to chemotherapy treatment)
- •Patients aged 19 to 75 years old
- •Those who can use prognosis management applications and can perform regular follow-up inspections outpatients
- •Patients carrying Android or iOS smartphones
- •Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study
排除标准
- •Those who are judged to be difficult to perform smartphone exercise and dietary management for colorectal cancer in general due to uncontrolled severe or underlying diseases, neuromuscular and musculoskeletal diseases
- •Serious complications of Clavein dindo classification grade 3 or higher after surgery
- •Patients who were not discharged within 2 weeks after surgery
结局指标
主要结局
Change of body composition (weight, kg)
时间窗: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found.
次要结局
- Change of Quality of life (EORTC-QLQ-C29)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Grip strength(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- The Wexner score(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Physical activity (IPAQ-SF)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- 2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)(postoperative 1month, 3month, 6month, 12month)
- Change of Quality of life (EORTC-QLQ-C30)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Pain (Numeric rating scale, NRS)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Lower extremity muscle endurance (30seconds chair stands test)(postoperative 1month, 3month, 6month, 12month)
- Nutrition assessment (Mini-nutrition assessment, MNA)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- LARS(Low Anterior Rectal Resection Syndrome) score questionnaire(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)