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Stage I Gastric CancerNCT04394585

Effect of Smart Phone App-based Human Coaching Program in Gastrectomized Patients

A study testing smart phone app based human coaching program in people with Stage I Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single center, prospective, randomized controlled study. The aim of this study is to evaluate the effect of smart phone app-based human coaching program on QOL in patients who underwent gastrectomy for stage I gastric cancer. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stage I Gastric Cancer
What is being tested?
smart phone app based human coaching program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSouth Korea
Study dates
11 May 2020to 31 Dec 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient aged 19 or more
  • patient diagnosed as stage I in preoperative examination
  • planned distal gastrectomy or total gastrectomy
  • patient who can use smart phone app or whose family can help the
  • patient to use the smart phone app

Who cannot join

  • pregnant
  • disabled to communication
  • patient who cannot use smart phone app

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Bang Wool Eom

    Goyang-si, Gyeonggi-do, 10408

Other trials in South Korea

About this study

Official title: A Study Evaluating Effect of Smart Phone App-based Human Coaching Program on QOL in Patients Who Underwent Gastrectomy for Stage I Gastric Cancer

This study is a single center, prospective, randomized controlled study. The aim of this study is to evaluate the effect of smart phone app-based human coaching program on QOL in patients who underwent gastrectomy for stage I gastric cancer. The hypothesis of this study is the patients who used smart phone app-based human coaching program for three months after surgery will have better QOL than patients who did not use it. The QOL will be assessed using EORTC QLQ C30 and STO22 at 3 months postoperatively. The secondary endpoints are QOL at 6 months postoperatively, 12 months postoperative, food intake, body composition, and nutritional indicators from blood test.

Read the detailed description

< Patient enrollment>

  • 90 patients in each group, a total of 180 patients
  • 1:1 Randomization using permutated mixed block randomization
  • stratified by surgical extent (distal gastrectomy vs. total gastrectomy)
  • using nQuery program and web-based management system
  • Before discharge, patients are informed how to use the smart phone app and registered to the app.
  • Patients use the app after discharge until 3 months postoperatively.
Being tested
smart phone app based human coaching program
Keywords
gastric cancer, quality of life, smart phone app, human coaching program
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • smart phone app based human coaching programBehavioural

    1. experimental arm
    • 1:1 coaching using smart phone app
    • Patients are provided several articles about postoperative care (symptom management, diet, and exercise) in the app.
    • Patients are encouraged to report their diet diaries and exercise everyday by the coach.
    • Patients can ask to the coach using the app and the coach answer when they check them.
    1. Comparator arm - Patient have consulting with clinical nutritionist at 1 month and 3 months postoperatively.
Study groups in NCT04394585
Study groupRoleWhat they receive
Smart phone app groupExperimentalPatients used smart phone app based human coaching program for 3 months postoperatively.
Receives: Behavioral: smart phone app based human coaching program
Nutritional consultation groupActive comparatorPatients have two consulting with clinical nutritionist at 1 month and 3 months postoperatively.
Receives: Behavioral: smart phone app based human coaching program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eating restriction score (XEatR) at 1 month postoperatively

    Eating resection scale is calculated according to the following equation. a. Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4): EatR = (Q41+Q42+Q43+Q46)/4 b. Carry out a linear transformation to convert to a 1-100 scale: XEatR = (EatR-1)*100/3 The 4 items are belong to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) STO22. Each item has a value among 1, 2, 3, and 4 according to the answer and the scale score has a value ranging 0 (minimum) to 100 (maximum). Higher scores mean having more symptom and worse quality of life.

    Measured: 1 month postoperatively

  2. Eating restriction score (XEatR) at 3 months postoperatively

    Eating resection scale is calcuated according to the following equation.

    1. Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4): EatR = (Q41+Q42+Q43+Q46)/4
    2. Carry out a linear transformation to convert to a 1-100 scale:

    XEatR = (EatR-1)*100/3

    The 4 items are belong to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) STO22.

    Each item has a value among 1, 2, 3, and 4 according to the answer and the scale score has a value ranging 0 (minimum) to 100 (maximum).

    Higher scores mean having more symptom and worse quality of life.

    Measured: 3 months postoperatively

Secondary outcomes (8)

  1. Eating restriction score (XEatR) at 6 months postoperatively

    Eating resection scale is calcuated according to the following equation.

    1. Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4): EatR = (Q41+Q42+Q43+Q46)/4
    2. Carry out a linear transformation to convert to a 1-100 scale:

    XEatR = (EatR-1)*100/3

    The 4 items are belong to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) STO22.

    Each item has a value among 1, 2, 3, and 4 according to the answer and the scale score has a value ranging 0 (minimum) to 100 (maximum).

    Higher scores mean having more symptom and worse quality of life.

    Measured: 6 months postoperatively

  2. Eating restriction score (XEatR) at 12 months postoperatively

    Eating resection scale is calcuated according to the following equation.

    1. Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4): EatR = (Q41+Q42+Q43+Q46)/4
    2. Carry out a linear transformation to convert to a 1-100 scale:

    XEatR = (EatR-1)*100/3

    The 4 items are belong to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) STO22.

    Each item has a value among 1, 2, 3, and 4 according to the answer and the scale score has a value ranging 0 (minimum) to 100 (maximum).

    Higher scores mean having more symptom and worse quality of life.

    Measured: 12 months postoperatively

  3. food intake

    difference of food amount between discharge day and postoperative 1 month

    Measured: discharge day: up to 3 weeks postoperatively,1 month postoperatively

  4. Body weight

    patient's weight in kilograms

    Measured: 3 months postoperatively

  5. serum albumin

    g/dL

    Measured: 3 months postoperatively

  6. serum protein

    g/dL

    Measured: 3 months postoperatively

  7. serum cholesterol

    g/dL

    Measured: 3 months postoperatively

  8. seum hemoglobin

    g/dL

    Measured: 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start11 May 2020
  3. Primary completion2 Nov 2022
  4. Study completion31 Dec 2023

Resources

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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04394585
Sponsor's protocol ID
1910242
Status last verified
Apr 2025
First submitted
10 May 2020
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eom BW, Han M, Yoon HM, Kim YW, Kim SY, Oh JM, Wie GA, Ryu KW. Improvement in Quality of Life After Early Interactive Human Coaching via a Mobile App in Postgastrectomy Patients With Gastric Cancer: Prospective Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Dec 18;13:e75445. doi: 10.2196/75445.

    PubMed 41411643

  • Kim HJ, Yoon HM, Ryu KW, Kim YW, Kim SY, Oh JM, Wie GA, Ko H, Lee J, Kim Y, Cho H, Eom BW. An early interactive human coaching via a mobile application to improve quality of life in patients who underwent gastrectomy for gastric cancer: Design and protocol of a randomized controlled trial. PLoS One. 2022 Dec 9;17(12):e0278370. doi: 10.1371/journal.pone.0278370. eCollection 2022.

    PubMed 36490244

Questions about this trial

What is this clinical trial studying?

A study testing smart phone app based human coaching program in people with Stage I Gastric Cancer, run by National Cancer Center, Korea 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 3 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: finished, as of the sponsor's last update on 13 Apr 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Eating restriction score (XEatR) at 1 month postoperatively (time frame: 1 month postoperatively). The study lists 2 primary outcomes in all. 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 NCT04394585, 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 13 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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