Clinical trial NCT04907591: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National IT Industry Promotion Agency
First posted: 2021-06-01
Enrollment: 324
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change of body composition (weight, kg)
timeFrame: between baseline (postoperative 2-3days) and postoperative 6 months
Secondary outcomes:
measure: Change of Quality of life (EORTC-QLQ-C30)
timeFrame: between baseline (postoperative 2-3days) and postoperative 6 months
measure: Pain (Numeric rating scale, NRS)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Self-reported symptom and Quality of life (EORTC-QLQ-STO22)
timeFrame: postoperative 1month, 3month, 6month, 12month
measure: Physical activity (IPAQ-SF)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Grip strength
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Lower extremity muscle endurance (30seconds chair stands test)
timeFrame: postoperative 1month, 3month, 6month, 12month
measure: 2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
timeFrame: postoperative 1month, 3month, 6month, 12month
measure: Nutrition assessment (Mini-nutrition assessment, MNA)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Visceral fat (㎠)
timeFrame: Enrollment (postoperative 2-3days), postoperative 6month, 12month
measure: Muscle mass (lumbar 2,㎠)
timeFrame: Enrollment (postoperative 2-3days), postoperative 6month, 12month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-gu
Study officials:
affiliation: Physical & Rehabilitation Medicine Samsung Medical Center
name: JIHYE HWANG, Professor
role: PRINCIPAL_INVESTIGATOR
References: