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

March 23, 2023 updated by: Bang Wool Eom, National Cancer Center, Korea

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 10408
        • Recruiting
        • Bang Wool Eom
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating restriction score (XEatR) at 3 months postoperatively
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating restriction score (XEatR) at 6 months postoperatively
Time Frame: 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.
6 months postoperatively
Eating restriction score (XEatR) at 12 months postoperatively
Time Frame: 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.
12 months postoperatively
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
discharge day: up to 3 weeks postoperatively,1 month postoperatively
Body weight
Time Frame: 3 months postoperatively
patient's weight in kilograms
3 months postoperatively
serum albumin
Time Frame: 3 months postoperatively
g/dL
3 months postoperatively
serum protein
Time Frame: 3 months postoperatively
g/dL
3 months postoperatively
serum cholesterol
Time Frame: 3 months postoperatively
g/dL
3 months postoperatively
seum hemoglobin
Time Frame: 3 months postoperatively
g/dL
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

November 2, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 16, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1910242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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