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NCT Number: NCT04394585

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

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.

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Key information

Conditions

Stage I Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bang Wool Eom

Goyang-si, Gyeonggi-do, 10408, South Korea

About this study

< 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smart phone app based human coaching program

Behavioral
  • 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.

Primary outcomes

  1. 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.

  2. Eating restriction score (XEatR) at 3 months postoperatively

    Time frame: 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.

Secondary outcomes

  1. Eating restriction score (XEatR) at 6 months postoperatively

    Time frame: 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.

  2. Eating restriction score (XEatR) at 12 months postoperatively

    Time frame: 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.

  3. food intake

    Time frame: discharge day: up to 3 weeks postoperatively,1 month postoperatively

    difference of food amount between discharge day and postoperative 1 month

  4. Body weight

    Time frame: 3 months postoperatively

    patient's weight in kilograms

  5. serum albumin

    Time frame: 3 months postoperatively

    g/dL

  6. serum protein

    Time frame: 3 months postoperatively

    g/dL

  7. serum cholesterol

    Time frame: 3 months postoperatively

    g/dL

  8. seum hemoglobin

    Time frame: 3 months postoperatively

    g/dL

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 19, 2020
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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