Stage I Gastric Cancer
Conditions
Keywords
gastric cancer, quality of life, smart phone app, human coaching program
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.
Interventions
BEHAVIORALsmart phone app based human coaching program
1. 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. 2. Comparator arm - Patient have consulting with clinical nutritionist at 1 month and 3 months postoperatively.
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eating restriction score (XEatR) at 1 month postoperatively | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| food intake | discharge day: up to 3 weeks postoperatively,1 month postoperatively | difference of food amount between discharge day and postoperative 1 month |
| Body weight | 3 months postoperatively | patient's weight in kilograms |
| serum albumin | 3 months postoperatively | g/dL |
| Eating restriction score (XEatR) at 6 months postoperatively | 6 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. |
| serum cholesterol | 3 months postoperatively | g/dL |
| seum hemoglobin | 3 months postoperatively | g/dL |
| serum protein | 3 months postoperatively | g/dL |
| Eating restriction score (XEatR) at 12 months postoperatively | 12 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. |
Countries
South Korea
Outcome results
None listed