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

Study Overview
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Brief Summary
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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
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< 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.

Official Title
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A Study Evaluating Effect of Smart Phone App-based Human Coaching Program on QOL in Patients Who Underwent Gastrectomy for Stage I Gastric Cancer

Conditions
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Stage I Gastric Cancer

Intervention / Treatment
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* Behavioral: smart phone app based human coaching program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart phone app group<br>Patients used smart phone app based human coaching program for 3 months postoperatively. | Behavioral: smart phone app based human coaching program<br>* 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.<br>|
| Active Comparator: Nutritional consultation group<br>Patients have two consulting with clinical nutritionist at 1 month and 3 months postoperatively. | Behavioral: smart phone app based human coaching program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| food intake | difference of food amount between discharge day and postoperative 1 month | discharge day: up to 3 weeks postoperatively,1 month postoperatively | 
| Body weight | patient's weight in kilograms | 3 months postoperatively | 
| serum albumin | g/dL | 3 months postoperatively | 
| serum protein | g/dL | 3 months postoperatively | 
| serum cholesterol | g/dL | 3 months postoperatively | 
| seum hemoglobin | g/dL | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, quality of life, smart phone app, human coaching program