Gastric CancerNCT04907591
Postoperative Prognosis Management Service Based mHealth for Gastric Cancer Patients
A study testing mHealth App and wearable device in people with Gastric Cancer, run by Samsung Medical Center 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 together with a smartphone application. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastric 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
- 17 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AJCC stage I-III who has undergone radical gastric cancer surgery (chemotherapy, radiation therapy is irrelevant)
- Patients aged 19 to 75 years old
- Those who can use prognosis management applications and can perform regular follow-up inspections outpatients
- Patients carrying Android or iOS smartphones
- Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study
Who cannot join
- Those who have difficulty using gastric cancer applications (exercise performance, diet management, etc.) due to severe underlying diseases, neuromusculoskeletal diseases, cognitive, and visual impairments
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
About this study
Official title: Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Gastric 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 together with 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. As a result of applying a mobile application for health management (nutrition, health education, exercise, etc.) to 203 gastric cancer or colon cancer patients undergoing chemotherapy in the previous study, gastric cancer patients are most interested in health-related education and information.
As such, it was possible to confirm the clinical significance of short-term and temporary health care through mobile applications and smart bands during the treatment process for gastric cancer patients, but the study was insufficient to generalize the number of subjects. Therefore, until now, the results of a multicenter randomized-control study have not been found after long-term application as a supportive tool from immediately after surgery (before treatment) to during the treatment process.
Read more
Therefore, in gastric cancer patients who need prognosis management after surgery, we will investigate the effect of mobile application with smart band which has a modular structure reflecting the treatment method and treatment process after surgery.
This study targets patients who underwent gastric cancer surgery, an intervention group (App+IoT device) uses a smart care application tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and a wearable smart band for 12 months. Control group was 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
- Gastric Cancer
- Being tested
- mHealth App and wearable device
- Medical subject headings
- Stomach 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 tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and a wearable smart band worn on wrist 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 tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and 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)
comparison between groups in change of weight between baseline (postoperative 2-3days) and postoperative 6 months
Measured: between baseline (postoperative 2-3days) and postoperative 6 months
Secondary outcomes (10)
Change of Quality of life (EORTC-QLQ-C30)
comparison between groups in change of quality of life between baseline (postoperative 2-3days) and postoperative day 6 months
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). Each scale includes a different set of items, which are calculated using specific coding procedures. Higher scores for the general health status and the functional scales imply positive results, whereas the symptom and the single-item scales are interpreted inversely.
Measured: between baseline (postoperative 2-3days) and postoperative 6 months
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). Higher score indicates higher pain.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Self-reported symptom and Quality of life (EORTC-QLQ-STO22)
According to time frame with between-group and within group, trends will be found. EORTC QLQ-STO22 is composed of 5 multi-item scales and 4 single-item measures. For the EORTC QLQSTO22, like symptom scales, a high score represents low QoL.
This questionnaire evaluates the effect of chemotherapy, radiation therapy on symptom and quality of life. Therefore, from postoperative 1 month, it will be evaluated.
Measured: postoperative 1month, 3month, 6month, 12month
Physical activity (IPAQ-SF)
According to time frame with between-group and within group, trends will be found. There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. Higher METs or category level indicates higher physical activity.
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.
Since this test is judged to have a mild effect of abdominal pain after surgery, it is evaluated from enrollment.
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 and stand up in a chair for 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: 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: 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 (MNA-SF) 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
Visceral fat (㎠)
According to time frame with between-group and within group, trends will be found.
Visceral fat at navel level measured by Computed Tomography
Measured: Enrollment (postoperative 2-3days), postoperative 6month, 12month
Muscle mass (lumbar 2,㎠)
According to time frame with between-group and within group, trends will be found.
Muscle mass at lumbar 2 measured by Computed Tomography
Measured: Enrollment (postoperative 2-3days), postoperative 6month, 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start17 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
- Investigators
- JIHYE HWANG, Professor, Principal investigator, Physical & Rehabilitation Medicine Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907591
- Sponsor's protocol ID
- NIPA AIoT_Cancer
- Status last verified
- Oct 2022
- First submitted
- 20 May 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim I, Lim JY, Kim SW, Lee JH, Sohn TS, Park S, Kang SH, Lee JY, Hwang JH. Effectiveness of a Personalized Digital Exercise and Nutrition Rehabilitation Program in Postoperative Patients With Gastric Cancer: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Feb 26;14:e85795. doi: 10.2196/85795.
PubMed 41747252Kim I, Lim JY, Kim JK, Lee JH, Sohn TS, Park S, Kang SH, Lee JY, Hwang JH. Effectiveness of a personalized digital exercise and nutrition-based rehab program for patients with gastric cancer after surgery: Study protocol for a randomized controlled trial. Digit Health. 2023 Jul 17;9:20552076231187602. doi: 10.1177/20552076231187602. eCollection 2023 Jan-Dec.
PubMed 37485329
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. 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 Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT04907591
- Acronym / sponsor ID
- NIPA AIoT_Cancer
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Study start
- 17 May 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 1 Jun 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 together with 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. As a result of applying a mobile application for health management (nutrition, health education, exercise, etc.) to 203 gastric cancer or colon cancer patients undergoing chemotherapy in the previous study, gastric cancer patients are most interested in health-related education and information.
As such, it was possible to confirm the clinical significance of short-term and temporary health care through mobile applications and smart bands during the treatment process for gastric cancer patients, but the study was insufficient to generalize the number of subjects. Therefore, until now, the results of a multicenter randomized-control study have not been found after long-term application as a supportive tool from immediately after surgery (before treatment) to during the treatment process.
Therefore, in gastric cancer patients who need prognosis management after surgery, we will investigate the effect of mobile application with smart band which has a modular structure reflecting the treatment method and treatment process after surgery.
This study targets patients who underwent gastric cancer surgery, an intervention group (App+IoT device) uses a smart care application tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and a wearable smart band for 12 months. Control group was 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 tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and 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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AJCC stage I-III who has undergone radical gastric cancer surgery (chemotherapy, radiation therapy is irrelevant)
- Patients aged 19 to 75 years old
- Those who can use prognosis management applications and can perform regular follow-up inspections outpatients
- Patients carrying Android or iOS smartphones
- Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study
Key exclusion criteria (1 listed)
- Those who have difficulty using gastric cancer applications (exercise performance, diet management, etc.) due to severe underlying diseases, neuromusculoskeletal diseases, cognitive, and visual impairments
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 tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and a wearable smart band worn on wrist for 12 months. | Device | mHealth App and wearable device |
Primary outcome
Change of body composition (weight, kg)
Time frame: between baseline (postoperative 2-3days) and postoperative 6 months
comparison between groups in change of weight between baseline (postoperative 2-3days) and postoperative 6 months
10 secondary outcomes
Change of Quality of life (EORTC-QLQ-C30)
Time frame: between baseline (postoperative 2-3days) and postoperative 6 months
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-STO22)
Time frame: postoperative 1month, 3month, 6month, 12month
Physical activity (IPAQ-SF)
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: postoperative 1month, 3month, 6month, 12month
2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
Time frame: postoperative 1month, 3month, 6month, 12month
Nutrition assessment (Mini-nutrition assessment, MNA)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Visceral fat (㎠)
Time frame: Enrollment (postoperative 2-3days), postoperative 6month, 12month
Muscle mass (lumbar 2,㎠)
Time frame: Enrollment (postoperative 2-3days), postoperative 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 Oct 2022.
- Derived from this study: PubMed 41747252Kim I, Lim JY, Kim SW, Lee JH, Sohn TS, Park S, Kang SH, Lee JY, Hwang JH. Effectiveness of a Personalized Digital Exercise and Nutrition Rehabilitation Program in Postoperative Patients With Gastric Cancer: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Feb 26;14:e85795. doi: 10.2196/85795.
- Derived from this study: PubMed 37485329Kim I, Lim JY, Kim JK, Lee JH, Sohn TS, Park S, Kang SH, Lee JY, Hwang JH. Effectiveness of a personalized digital exercise and nutrition-based rehab program for patients with gastric cancer after surgery: Study protocol for a randomized controlled trial. Digit Health. 2023 Jul 17;9:20552076231187602. doi: 10.1177/20552076231187602. eCollection 2023 Jan-Dec.
- 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.
JIHYE HWANG, Professor principal investigator
Physical & Rehabilitation Medicine Samsung Medical Center
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 Gastric Cancer, run by Samsung Medical Center 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 1 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 Oct 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body composition (weight, kg) (time frame: between baseline (postoperative 2-3days) and postoperative 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04907591, which also lists 2 linked publications.
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 Oct 2022.