Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Prostate Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021952
• Other study ID #: NIPA AIoT_Cancer
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: August 2021
• Source: Seoul St. Mary's Hospital
• Contact: JIYOUL LEE, Professor
• Phone: 82-10-8945-3843
• Email: uroljy[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul	Seongbuk-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	National IT Industry Promotion Agency

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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).	Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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