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| Name | Class |
|---|---|
| National IT Industry Promotion Agency, South Korea | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth App and wearable device | Experimental | 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. |
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| Education brochure | No Intervention | Control group is provided general education through the hospital brochure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth App and wearable device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body composition (weight, kg) | According to time frame with between-group and within group, trends will be found. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Quality of life (EORTC-QLQ-C30) | According to time frame with between-group and within group, trends will be found. This questionnaire contains 30 items regarding general health status, five functional scales (ie, physical, role, cognitive, emotional, and social functioning), three symptom scales (ie, fatigue, pain, and nausea or vomiting), and six single-item scales (ie, dyspnea, appetite loss, constipation, diarrhea, financial difficulties, and insomnia). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIYOUL LEE, Professor | Contact | 82-10-8945-3843 | uroljy@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| JIYOUL LEE, Professor | Department of Urology Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | Seongbuk-gu | 02841 | South Korea |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Pain (Numeric rating scale, NRS) | According to time frame with between-group and within group, trends will be found. NRS score (11 point scales) ranges from 0 (no pain) to 10 (possible to image maximum pain). A higher score means more pain. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Self-reported symptom and Quality of life (EORTC-QLQ-PR25) | According to time frame with between-group and within group, trends will be found. EORTC-QLQ-PR25 consists of 25 questions and identifies various symptoms or problems that patients may experience. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Physical activity (IPAQ-SF) | According to time frame with between-group and within group, trends will be found. IPAQ-SF finds out about the physical activities that patients do on a daily basis. This includes activities that patients do at work or at home, activities they do while using transportation, activities they do in their spare time, and exercise. This questionnaire consists of 7 questions. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Urination Symptom (ICIQ-SF) | According to time frame with between-group and within group, trends will be found. ICIQ-SF is about the urine symptom that patients are experiencing, and consists of a total of 4 questions. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Overactive Bladder Symptom (OABSS) | According to time frame with between-group and within group, trends will be found. OABSS is a questionnaire about overactive bladder symptom and consists of a total of 4 items. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Prostatic Hyperplasia (IPSS) | According to time frame with between-group and within group, trends will be found. IPSS is a questionnaire about prostatic hyperplasia to find out uncomfortable symptoms that may appear when urinating. This questionnaire consists of 8 questions. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Erectile Dysfunction Symptom (IIEF-5) | According to time frame with between-group and within group, trends will be found. IIEF-5 is a questionnaire about the symptoms of erectile dysfunction that may appear after surgery, and consists of 5 questions. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Grip strength | According to time frame with between-group and within group, trends will be found. Using a grip dynamometer, take three measurements on both hands. Higher value (kg) indicates higher grip strength. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Lower extremity muscle endurance (30seconds chair stands test) | According to time frame with between-group and within group, trends will be found. It measures the number of times you sit down and stand up from a chair in 30 seconds. Higher value (number) indicates higher lower extremity muscle endurance. It is judged that the 30seconds chair stands test will be difficult due to abdominal pain after surgery, so the evaluation is performed only at the other F/U points excluding the enrollment date. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| 2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance) | According to time frame with between-group and within group, trends will be found. The 2MWT is a measurement of endurance that assesses walking distance over two minutes. It is judged that the 2MWT will be difficult due to abdominal pain after surgery, so the evaluation is performed only at the other F/U points excluding the enrollment date. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| Nutrition assessment (Mini-nutrition assessment, MNA) | According to time frame with between-group and within group, trends will be found. The short form of the MNA (MNASF) is a screening tool consisting of six questions on food intake, weight loss, mobility, psychological stress, or acute disease, the presence of dementia or depression, and body mass index (BMI). The maximum score for this part is equal to 14. A score equal to or higher than 12 indicates that the subject under study has an acceptable nutritional status thus excluding malnutrition and/or malnutrition risk, meanwhile, a score ≤ 11 implicates to proceed with the complete version of the MNA (MNA-LF). This version consists of 12 additional items and provides a maximum possible overall assessment of 30 scores: a score of fewer than 17 indicates malnutrition, a score of 17-23.5 indicates a risk for malnutrition and a score higher 23.5 indicates well-nourishment. | Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |