Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 324
- 试验地点
- 1
- 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 prostate 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients 19 years of age or older who have been diagnosed with prostate cancer
- •Patients who have completed surgical treatment for cancer within 3 months of screening and have no additional treatment planned
- •Patients who can use a prognosis management application and can perform regular follow-up examinations in outpatient settings
- •Patients carrying an Android or iOS smartphone
- •Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study
排除标准
- •Patients who have been treated within the last 3 months for other serious diseases (hematologic cancer, malignancy, etc.)
- •Patients for whom additional treatment was planned due to cancer recurrence or metastasis
- •Patients with severe cardiopulmonary disease who are unable to proceed with rehabilitation exercise programs
- •Patients who find it difficult to proceed with the rehabilitation exercise program due to pain caused by bone metastasis and concerns about pathological fractures
- •Patients who underwent lower extremity artificial joint TKRA and THRA
- •Patients who are not eligible for rehabilitation exercise as judged by medical personnel
研究组 & 干预措施
mHealth App and wearable device
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.
干预措施: mHealth App and wearable device (Device)
Education brochure
Control group is provided general education through the hospital brochure.
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-C30)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Pain (Numeric rating scale, NRS)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Self-reported symptom and Quality of life (EORTC-QLQ-PR25)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Physical activity (IPAQ-SF)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Urination Symptom (ICIQ-SF)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Overactive Bladder Symptom (OABSS)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Prostatic Hyperplasia (IPSS)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Erectile Dysfunction Symptom (IIEF-5)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Grip strength(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Lower extremity muscle endurance (30seconds chair stands test)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- 2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
- Nutrition assessment (Mini-nutrition assessment, MNA)(Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month)
研究者
Ji Youl Lee
Professor
Seoul St. Mary's Hospital