Clinical trial NCT04394585: Effect of Smart Phone App-based Human Coaching Program in Gastrectomized Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage I Gastric Cancer
Keywords: gastric cancer
quality of life
smart phone app
human coaching program
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2020-05-19
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eating restriction score (XEatR) at 1 month postoperatively
timeFrame: 1 month postoperatively
measure: Eating restriction score (XEatR) at 3 months postoperatively
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Eating restriction score (XEatR) at 6 months postoperatively
timeFrame: 6 months postoperatively
measure: Eating restriction score (XEatR) at 12 months postoperatively
timeFrame: 12 months postoperatively
measure: food intake
timeFrame: discharge day: up to 3 weeks postoperatively,1 month postoperatively
measure: Body weight
timeFrame: 3 months postoperatively
measure: serum albumin
timeFrame: 3 months postoperatively
measure: serum protein
timeFrame: 3 months postoperatively
measure: serum cholesterol
timeFrame: 3 months postoperatively
measure: seum hemoglobin
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Bang Wool Eom
state: Gyeonggi-do
Study officials:
References: