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

Not Applicable

Completed

• Conditions: Stage I Gastric Cancer

• Registration Number: NCT04394585
• Lead Sponsor: National Cancer Center, Korea

Brief 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. 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.

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.

Study Timeline

• Study First Submitted: 2020-05-10
• Study Start: 2020-05-11
• Study First Submitted QC: 2020-05-16
• Study First Posted: 2020-05-19
• Primary Completion: 2022-11-02
• Study Completion: 2023-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Eating restriction score (XEatR) at 1 month postoperatively	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.
Eating restriction score (XEatR) at 3 months postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Eating restriction score (XEatR) at 6 months postoperatively	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.
food intake	discharge day: up to 3 weeks postoperatively,1 month postoperatively	difference of food amount between discharge day and postoperative 1 month
Body weight	3 months postoperatively	patient's weight in kilograms
Eating restriction score (XEatR) at 12 months postoperatively	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.
serum cholesterol	3 months postoperatively	g/dL
serum albumin	3 months postoperatively	g/dL
seum hemoglobin	3 months postoperatively	g/dL
serum protein	3 months postoperatively	g/dL

Trial Locations

Locations (1)

Bang Wool Eom; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of