NCT06395935

Brief Summary

The KOrean QUality of life in Stomach cancer patients Study group (KOQUSS) made a method (KOQUSS-40) for assessing appropriately the quality of life of gastric cancer patients who have undergone gastrectomy, and developed a digital platform (Wecare) based on KOQUSS-40. In this study, we propose a randomized controlled trial to compare quality of life after gastrectomy in patients with and without smartphone app support.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

April 29, 2024

Last Update Submit

October 10, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • the quality of life in gastric cancer survivor (KOQUSS-40)

    KOQUSS-40 questionnaire has a 40-item questionnaire in 11 domains focusing on the symptoms evaluation after gastric cancer surgery.

    at 1, 3, and 6 months after surgery in the outpatient clinic.

Secondary Outcomes (3)

  • Weight

    at 1, 3, and 6 months after surgery in the outpatient clinic.

  • nutritional index

    at 1, 3, and 6 months after surgery in the outpatient clinic.

  • KOQUSS-40 questionnaire compliance

    at 1, 3, and 6 months after surgery in the outpatient clinic.

Study Arms (2)

conventional group

NO INTERVENTION

In the control group, participants will be asked to complete written questionnaires in the outpatient clinic before surgery and at 1, 3, and 6 months after surgery. Based on the questionnaires, a clinician will provide a solution at an outpatient clinic. However, the Wecare® platform was not provided. .

Wecare group

EXPERIMENTAL

In the intervention group, participants will be asked to use the Wecare® platform (Figure 2). The Wecare® platform administers QoL questionnaires, including the KOQUSS-40 and EORTC QLQ-C30, following gastrectomy to treat gastric cancer. Based on participants' responses, The platform automatically generates expert recommendations from gastric cancer specialists based on participants' responses according to the timing of surgery after gastrectomy. Furthermore, the Wecare® platform offers educational materials on gastric cancer to address participants' questions about the disease. Participants will be free to use the platform but will be asked to visit the Wecare® platform at least once a month and answer questionnaires. Participants will visit an outpatient clinic before surgery and at 1, 3, and 6 months after surgery.

Other: Wecare (website)

Interventions

Wecare (website)OTHER

support feedback of qutionaire \& supply educational contents

Wecare group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient (19-75 years) who underwent radical gastrectomy

You may not qualify if:

  • Patients who were unable to undergo regular follow-up, lacked communication, or were deemed unsuitable to participate in this study by the researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyeongsang National University Hospital

Changwon, Gyeongsandnam-do, 51472, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Sang-Ho Jeong, MD

    Gyeongsang National University Changwon Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sook-Ran Park

CONTACT

+82552142318sr0218@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

April 1, 2024

Primary Completion

November 30, 2025

Study Completion

March 30, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

if request, we can share the IPD without personal data.

Shared Documents
STUDY PROTOCOL
Time Frame
The study was finished, the data can available
Access Criteria
Fore researcher, not for business model

Locations

KR(1)