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

NCT04394585 | Completed

• 1 other identifier: 1910242
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Gastric Cancer

Keywords

gastric cancer; quality of life; smart phone app; human coaching program

Outcome Measures

Primary Outcomes (2)

• Eating restriction score (XEatR) at 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.

  1 month postoperatively

• Eating restriction score (XEatR) at 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.

  3 months postoperatively

Secondary Outcomes (8)

• Eating restriction score (XEatR) at 6 months postoperatively

  6 months postoperatively

• Eating restriction score (XEatR) at 12 months postoperatively

  12 months postoperatively

• food intake

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

• Body weight

  3 months postoperatively

• serum albumin

  3 months postoperatively

Study Arms (2)

Smart phone app group

EXPERIMENTAL

Patients used smart phone app based human coaching program for 3 months postoperatively.

Behavioral: smart phone app based human coaching program

Nutritional consultation group

ACTIVE COMPARATOR

Patients have two consulting with clinical nutritionist at 1 month and 3 months postoperatively.

Behavioral: smart phone app based human coaching program

Interventions

smart phone app based human coaching program BEHAVIORAL

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.

Nutritional consultation group; Smart phone app group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant
• disabled to communication
• patient who cannot use smart phone app

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

Bang Wool Eom

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

Location

Related Publications (2)

• Eom BW, Han M, Yoon HM, Kim YW, Kim SY, Oh JM, Wie GA, Ryu KW. Improvement in Quality of Life After Early Interactive Human Coaching via a Mobile App in Postgastrectomy Patients With Gastric Cancer: Prospective Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Dec 18;13:e75445. doi: 10.2196/75445.

  PMID: 41411643 DERIVED

• Kim HJ, Yoon HM, Ryu KW, Kim YW, Kim SY, Oh JM, Wie GA, Ko H, Lee J, Kim Y, Cho H, Eom BW. An early interactive human coaching via a mobile application to improve quality of life in patients who underwent gastrectomy for gastric cancer: Design and protocol of a randomized controlled trial. PLoS One. 2022 Dec 9;17(12):e0278370. doi: 10.1371/journal.pone.0278370. eCollection 2022.

  PMID: 36490244 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 19, 2020
• Study Start: May 11, 2020
• Primary Completion: November 2, 2022
• Study Completion: December 31, 2023
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)