Postoperative Prognosis Management Service Based mHealth for Gastric Cancer Patients

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Device: mHealth App and wearable device

• Study Type: Interventional
• Enrollment (Anticipated): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongbuk-gu
    • Seoul, Seongbuk-gu, Korea, Republic of, 02841
      • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mHealth App and wearable device; 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.	Device: mHealth App and wearable device; 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.
No Intervention: Education brochure; Control group is provided general education through the hospital brochure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body composition (weight, kg)	comparison between groups in change of weight between baseline (postoperative 2-3days) and postoperative 6 months	between baseline (postoperative 2-3days) and postoperative 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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	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	Enrollment (postoperative 2-3days), postoperative 6month, 12month

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: National IT Industry Promotion Agency
• Investigators: Principal Investigator: JIHYE HWANG, Professor, Physical & Rehabilitation Medicine Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: NIPA AIoT_Cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No