Prostate CancerNCT05021952
Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients
A study testing mHealth App and wearable device in people with Prostate Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- mHealth App and wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
Seokho Kang, Professor, 82-10-9928-8097, mdksh@korea.ac.kr
Seokho Kang, Professor
About this study
Official title: Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Prostate Cancer Patients
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.
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- mHealth App and wearable device
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth App and wearable deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: mHealth App and wearable device |
| Education brochure | No intervention | Control group is provided general education through the hospital brochure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body composition (weight, kg)
According to time frame with between-group and within group, trends will be found.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Secondary outcomes (12)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start21 May 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Responsible party
- Principal investigator, Ji Youl Lee, Seoul St. Mary's Hospital
- Investigators
- JIYOUL LEE, Professor, Principal investigator, Department of Urology Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021952
- Sponsor's protocol ID
- NIPA AIoT_Cancer
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT05021952
- Acronym / sponsor ID
- NIPA AIoT_Cancer
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth App and wearable device | Experimental | Device: mHealth App and wearable deviceAn 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. |
| Education brochure | No intervention | –Control group is provided general education through the hospital brochure. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth App and wearable deviceAn 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. | Device | mHealth App and wearable device |
Primary outcome
Change of body composition (weight, kg)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found.
12 secondary outcomes
Change of Quality of life (EORTC-QLQ-C30)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Pain (Numeric rating scale, NRS)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Self-reported symptom and Quality of life (EORTC-QLQ-PR25)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Physical activity (IPAQ-SF)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Urination Symptom (ICIQ-SF)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Overactive Bladder Symptom (OABSS)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Prostatic Hyperplasia (IPSS)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Erectile Dysfunction Symptom (IIEF-5)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Grip strength
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Lower extremity muscle endurance (30seconds chair stands test)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Nutrition assessment (Mini-nutrition assessment, MNA)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIYOUL LEE, Professor principal investigator
Department of Urology Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth App and wearable device in people with Prostate Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIYOUL LEE, Professor (82-10-8945-3843, uroljy@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body composition (weight, kg) (time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.