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

Primary Purpose

Stage I Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
smart phone app based human coaching program
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage I Gastric Cancer focused on measuring gastric cancer, quality of life, smart phone app, human coaching program

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bang Wool EomRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smart phone app group

Nutritional consultation group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
food intake
difference of food amount between discharge day and postoperative 1 month
Body weight
patient's weight in kilograms
serum albumin
g/dL
serum protein
g/dL
serum cholesterol
g/dL
seum hemoglobin
g/dL

Full Information

First Posted
May 10, 2020
Last Updated
March 23, 2023
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04394585
Brief Title
Effect of Smart Phone App-based Human Coaching Program in Gastrectomized Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Gastric Cancer
Keywords
gastric cancer, quality of life, smart phone app, human coaching program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smart phone app group
Arm Type
Experimental
Arm Description
Patients used smart phone app based human coaching program for 3 months postoperatively.
Arm Title
Nutritional consultation group
Arm Type
Active Comparator
Arm Description
Patients have two consulting with clinical nutritionist at 1 month and 3 months postoperatively.
Intervention Type
Behavioral
Intervention Name(s)
smart phone app based human coaching program
Intervention Description
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 Outcome Measure Information:
Title
Eating restriction score (XEatR) at 3 months postoperatively
Description
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.
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Eating restriction score (XEatR) at 6 months postoperatively
Description
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.
Time Frame
6 months postoperatively
Title
Eating restriction score (XEatR) at 12 months postoperatively
Description
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.
Time Frame
12 months postoperatively
Title
food intake
Description
difference of food amount between discharge day and postoperative 1 month
Time Frame
discharge day: up to 3 weeks postoperatively,1 month postoperatively
Title
Body weight
Description
patient's weight in kilograms
Time Frame
3 months postoperatively
Title
serum albumin
Description
g/dL
Time Frame
3 months postoperatively
Title
serum protein
Description
g/dL
Time Frame
3 months postoperatively
Title
serum cholesterol
Description
g/dL
Time Frame
3 months postoperatively
Title
seum hemoglobin
Description
g/dL
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bang Wool Eom, PhD
Phone
82-31-920-1689
Email
kneeling79@ncc.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunju Cho
Phone
82-31-920-0661
Email
74093@ncc.re.kr
Facility Information:
Facility Name
Bang Wool Eom
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bang Wool Eom, MD,PhD
Phone
82-31-920-1689
Email
kneeling79@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Hong Man Yoon, MD
Phone
8-31-920-1710
Email
red10000@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Bang Wool Eom, MD,PhD
First Name & Middle Initial & Last Name & Degree
Keun Won Ryu, MD,PhD
First Name & Middle Initial & Last Name & Degree
Young-Woo Kim, MD,PhD
First Name & Middle Initial & Last Name & Degree
Hong Man Yoon, MD,MS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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