Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mHealth App and wearable device
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Korea University Anam HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mHealth App and wearable device
Education brochure
Arm Description
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.
Outcomes
Primary Outcome Measures
Change of body composition (weight, kg)
According to time frame with between-group and within group, trends will be found.
Secondary Outcome Measures
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05021952
First Posted
August 19, 2021
Last Updated
August 19, 2021
Sponsor
Seoul St. Mary's Hospital
Collaborators
National IT Industry Promotion Agency
1. Study Identification
Unique Protocol Identification Number
NCT05021952
Brief Title
Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients
Official Title
Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
Collaborators
National IT Industry Promotion Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mHealth App and wearable device
Arm Type
Experimental
Arm Description
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.
Arm Title
Education brochure
Arm Type
No Intervention
Arm Description
Control group is provided general education through the hospital brochure.
Intervention Type
Device
Intervention Name(s)
mHealth App and wearable device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of body composition (weight, kg)
Description
According to time frame with between-group and within group, trends will be found.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Secondary Outcome Measure Information:
Title
Change of Quality of life (EORTC-QLQ-C30)
Description
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).
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Pain (Numeric rating scale, NRS)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Self-reported symptom and Quality of life (EORTC-QLQ-PR25)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Physical activity (IPAQ-SF)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Urination Symptom (ICIQ-SF)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Overactive Bladder Symptom (OABSS)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Prostatic Hyperplasia (IPSS)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Erectile Dysfunction Symptom (IIEF-5)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Grip strength
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Lower extremity muscle endurance (30seconds chair stands test)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Nutrition assessment (Mini-nutrition assessment, MNA)
Description
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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIYOUL LEE, Professor
Phone
82-10-8945-3843
Email
uroljy@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIYOUL LEE, Professor
Organizational Affiliation
Department of Urology Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seongbuk-gu
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seokho Kang, Professor
Phone
82-10-9928-8097
Email
mdksh@korea.ac.kr
First Name & Middle Initial & Last Name & Degree
Seokho Kang, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients
We'll reach out to this number within 24 hrs