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

Stage I Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04394585
• Other study ID #: 1910242
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National Cancer Center, Korea
• Contact: Bang Wool Eom, PhD
• Phone: 82-31-920-1689
• Email: kneeling79[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2023
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stage I Gastric Cancer
• Stomach Neoplasms

Intervention

Behavioral:
• smart phone app based human coaching program
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. Comparator arm - Patient have consulting with clinical nutritionist at 1 month and 3 months postoperatively.

Locations

Country	Name	City	State
Korea, Republic of	Bang Wool Eom	Goyang	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating restriction score (XEatR) at 3 months postoperatively	Eating resection scale is calcuated according to the following equation.; Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4): EatR = (Q41+Q42+Q43+Q46)/4; 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.	3 months postoperatively
Secondary	Eating restriction score (XEatR) at 6 months postoperatively	Eating resection scale is calcuated according to the following equation.; Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4): EatR = (Q41+Q42+Q43+Q46)/4; 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.	6 months postoperatively
Secondary	Eating restriction score (XEatR) at 12 months postoperatively	Eating resection scale is calcuated according to the following equation.; Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4): EatR = (Q41+Q42+Q43+Q46)/4; 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.	12 months postoperatively
Secondary	food intake	difference of food amount between discharge day and postoperative 1 month	discharge day: up to 3 weeks postoperatively,1 month postoperatively
Secondary	Body weight	patient's weight in kilograms	3 months postoperatively
Secondary	serum albumin	g/dL	3 months postoperatively
Secondary	serum protein	g/dL	3 months postoperatively
Secondary	serum cholesterol	g/dL	3 months postoperatively
Secondary	seum hemoglobin	g/dL	3 months postoperatively