NCT04394585

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage I Gastric Cancer

Interventions

Type	Name	Description
BEHAVIORAL	smart phone app based human coaching program	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. 2. Comparator arm - Patient have consulting with clinical nutritionist at 1 month and 3 months postoperatively.

Timeline

• Start date: 2020-05-11
• Primary completion: 2022-11-02
• Completion: 2023-12-31
• First posted: 2020-05-19
• Last updated: 2025-04-13

Locations

1 site across 1 country: South Korea