NCT04907591

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
324

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started May 2021

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

May 20, 2021

Last Update Submit

October 25, 2022

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Change of Quality of life (EORTC-QLQ-C30)

    between baseline (postoperative 2-3days) and postoperative 6 months

  • Pain (Numeric rating scale, NRS)

    Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

  • Self-reported symptom and Quality of life (EORTC-QLQ-STO22)

    postoperative 1month, 3month, 6month, 12month

  • Physical activity (IPAQ-SF)

    Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

  • Grip strength

    Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

  • +5 more secondary outcomes

Study Arms (2)

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.

Device: mHealth App and wearable device

Education brochure

NO INTERVENTION

Control group is provided general education through the hospital brochure.

Interventions

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.

mHealth App and wearable device

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

Related Publications (1)

  • Kim 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.

    PMID: 37485329DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • JIHYE HWANG, Professor

    Physical & Rehabilitation Medicine Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 1, 2021

Study Start

May 17, 2021

Primary Completion

May 30, 2023

Study Completion

May 30, 2024

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)