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

NCT ID: NCT04394585

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2023-12-31

Brief Summary

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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

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\< 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.

Conditions

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Stage I Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Smart phone app group

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

Group Type EXPERIMENTAL

smart phone app based human coaching program

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

smart phone app based human coaching program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bang Wool Eom

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bang Wool Eom

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36490244 (View on PubMed)

Other Identifiers

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1910242

Identifier Type: -

Identifier Source: org_study_id

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