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Postoperative Prognosis Management Service Based mHealth for Gastric Cancer Patients

Primary Purpose

Gastric Cancer

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mHealth App and wearable device
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Those who have difficulty using gastric cancer applications (exercise performance, diet management, etc.) due to severe underlying diseases, neuromusculoskeletal diseases, cognitive, and visual impairments

Sites / Locations

  • Korea University Anam Hospital

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 tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and 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)
comparison between groups in change of weight between baseline (postoperative 2-3days) and postoperative 6 months

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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 (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.
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
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

Full Information

First Posted
May 20, 2021
Last Updated
October 25, 2022
Sponsor
Samsung Medical Center
Collaborators
National IT Industry Promotion Agency
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1. Study Identification

Unique Protocol Identification Number
NCT04907591
Brief Title
Postoperative Prognosis Management Service Based mHealth for Gastric Cancer Patients
Official Title
Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Gastric Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 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
Samsung Medical Center
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric 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 tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and 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 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.
Primary Outcome Measure Information:
Title
Change of body composition (weight, kg)
Description
comparison between groups in change of weight between baseline (postoperative 2-3days) and postoperative 6 months
Time Frame
between baseline (postoperative 2-3days) and postoperative 6 months
Secondary Outcome Measure Information:
Title
Change of Quality of life (EORTC-QLQ-C30)
Description
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.
Time Frame
between baseline (postoperative 2-3days) and postoperative 6 months
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). Higher score indicates higher pain.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Self-reported symptom and Quality of life (EORTC-QLQ-STO22)
Description
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.
Time Frame
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. 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.
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. Since this test is judged to have a mild effect of abdominal pain after surgery, it is evaluated from enrollment.
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 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.
Time Frame
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
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 (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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Visceral fat (㎠)
Description
According to time frame with between-group and within group, trends will be found. Visceral fat at navel level measured by Computed Tomography
Time Frame
Enrollment (postoperative 2-3days), postoperative 6month, 12month
Title
Muscle mass (lumbar 2,㎠)
Description
According to time frame with between-group and within group, trends will be found. Muscle mass at lumbar 2 measured by Computed Tomography
Time Frame
Enrollment (postoperative 2-3days), postoperative 6month, 12month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Those who have difficulty using gastric cancer applications (exercise performance, diet management, etc.) due to severe underlying diseases, neuromusculoskeletal diseases, cognitive, and visual impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIHYE HWANG, Professor
Organizational Affiliation
Physical & Rehabilitation Medicine Samsung Medical Center
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Prognosis Management Service Based mHealth for Gastric Cancer Patients

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