A Study Evaluating Effect of Smart Phone App-based Human Coaching Program on QOL in Patients Who Underwent Gastrectomy for Stage I Gastric Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stage I Gastric Cancer
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Eating restriction score (XEatR) at 1 month postoperatively
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Bang Wool Eom
Dr
National Cancer Center, Korea
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
- •disabled to communication
- •patient who cannot use smart phone app
Outcomes
Primary Outcomes
Eating restriction score (XEatR) at 1 month postoperatively
Time Frame: 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
Time Frame: 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 Outcomes
- serum albumin(3 months postoperatively)
- Eating restriction score (XEatR) at 6 months postoperatively(6 months postoperatively)
- seum hemoglobin(3 months postoperatively)
- food intake(discharge day: up to 3 weeks postoperatively,1 month postoperatively)
- Body weight(3 months postoperatively)
- Eating restriction score (XEatR) at 12 months postoperatively(12 months postoperatively)
- serum protein(3 months postoperatively)
- serum cholesterol(3 months postoperatively)