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

National Cancer Center (NCC)

Status: Completed

Conditions: Stage I Gastric Cancer

Treatments: Behavioral: smart phone app based human coaching program

Study type: Interventional

Funder types: Other

Identifiers

NCT04394585

1910242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Smart phone app group

Experimental group

Description:

Patients used smart phone app based human coaching program for 3 months postoperatively.

Treatment:

Behavioral: smart phone app based human coaching program

Nutritional consultation group

Active Comparator group

Description:

Patients have two consulting with clinical nutritionist at 1 month and 3 months postoperatively.

Treatment:

Behavioral: smart phone app based human coaching program