Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Gastric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 together with 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. As a result of applying a mobile application for health management (nutrition, health education, exercise, etc.) to 203 gastric cancer or colon cancer patients undergoing chemotherapy in the previous study, gastric cancer patients are most interested in health-related education and information.
As such, it was possible to confirm the clinical significance of short-term and temporary health care through mobile applications and smart bands during the treatment process for gastric cancer patients, but the study was insufficient to generalize the number of subjects. Therefore, until now, the results of a multicenter randomized-control study have not been found after long-term application as a supportive tool from immediately after surgery (before treatment) to during the treatment process.
Therefore, in gastric cancer patients who need prognosis management after surgery, we will investigate the effect of mobile application with smart band which has a modular structure reflecting the treatment method and treatment process after surgery.
This study targets patients who underwent gastric cancer surgery, an intervention group (App+IoT device) uses a smart care application tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and a wearable smart band for 12 months. Control group was 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
- Supportive Care
- 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
- •AJCC stage I-III who has undergone radical gastric cancer surgery (chemotherapy, radiation therapy is irrelevant)
- •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 have difficulty using gastric cancer applications (exercise performance, diet management, etc.) due to severe underlying diseases, neuromusculoskeletal diseases, cognitive, and visual impairments
结局指标
主要结局
Change of body composition (weight, kg)
时间窗: between baseline (postoperative 2-3days) and postoperative 6 months
comparison between groups in change of weight between baseline (postoperative 2-3days) and postoperative 6 months
次要结局
- Grip strength(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Self-reported symptom and Quality of life (EORTC-QLQ-STO22)(postoperative 1month, 3month, 6month, 12month)
- Physical activity (IPAQ-SF)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Nutrition assessment (Mini-nutrition assessment, MNA)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Change of Quality of life (EORTC-QLQ-C30)(between baseline (postoperative 2-3days) and postoperative 6 months)
- 2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)(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)
- Muscle mass (lumbar 2,㎠)(Enrollment (postoperative 2-3days), postoperative 6month, 12month)
- Visceral fat (㎠)(Enrollment (postoperative 2-3days), postoperative 6month, 12month)
研究者
JiHye Hwang
Professor
Samsung Medical Center