A Study Evaluating Effect of Smart Phone App-based Human Coaching Program on QOL in Patients Who Underwent Gastrectomy for Stage I Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Eating restriction score (XEatR) at 1 month postoperatively
研究概览
简要总结
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.
详细描述
< 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •disabled to communication
- •patient who cannot use smart phone app
研究组 & 干预措施
Smart phone app group
Patients used smart phone app based human coaching program for 3 months postoperatively.
干预措施: smart phone app based human coaching program (Behavioral)
Nutritional consultation group
Patients have two consulting with clinical nutritionist at 1 month and 3 months postoperatively.
干预措施: smart phone app based human coaching program (Behavioral)
结局指标
主要结局
Eating restriction score (XEatR) at 1 month postoperatively
时间窗: 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
时间窗: 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.
次要结局
- serum cholesterol(3 months postoperatively)
- 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)
研究者
Bang Wool Eom
Dr
National Cancer Center, Korea