Wecare Study in Gastric Cancer Survivors

October 10, 2024 updated by: Gyeongsang National University Hospital

A Multi-center, Prospective, Randomized Study to Evaluate the Usefulness of Applying the Chronic Side Effect Management Platform (Wecare) in Gastric Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Smartphone apps have been gaining popularity in the delivery of lifestyle interventions in chronic disease management. In patients with cancer, randomized clinical trials have investigated the effect of smartphone-based interventions and reported improved quality of recovery and equal satisfaction with care compared with conventional in-person follow-up. However, there are no studies yet in which smartphone apps have evaluated the quality of life in patients after gastric cancer surgery.

Surgery is the mainstay of gastric cancer treatment. The proportion of patients with early gastric cancer and their survival rate of gastric cancer patients are increasing in East Asia thanks to the nationwide endoscopy screening program. As the number of long-term survivors after gastric cancer surgery increases, interest in the quality of life after surgery is also increasing. After gastrectomy, the remaining stomach volume is reduced or lost, and the vagus nerve is damaged during the surgery, which has various effects on the motor function and hormone secretion function of the stomach. Patients experience postgastrectomy syndrome, which includes lethargy, decreased appetite, early satiety, weight loss, abdominal distension, gastroesophageal reflux symptoms, diarrhea, anemia, and dumping syndrome. In addition to these physical symptoms, patients experience various symptoms and aftereffects after stomach cancer surgery, including psychological reactions such as fear, anxiety, and depression, and social problems such as avoidance of interpersonal relationships, social isolation, and difficulty returning to society.

Study Type

Interventional

Enrollment (Estimated)

88

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 Locations

  • Korea, Republic of
    • Gyeongsandnam-do
      • Changwon, Gyeongsandnam-do, Korea, Republic of, 51472
        • Recruiting
        • Gyeongsang National University Hospital
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: conventional group
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. .
Experimental: Wecare group
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)
support feedback of qutionaire & supply educational contents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the quality of life in gastric cancer survivor (KOQUSS-40)
Time Frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
Weight change
at 1, 3, and 6 months after surgery in the outpatient clinic.
nutritional index
Time Frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
nutritional index change
at 1, 3, and 6 months after surgery in the outpatient clinic.
KOQUSS-40 questionnaire compliance
Time Frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
check the KOQUSS-40 questionnaire compliance
at 1, 3, and 6 months after surgery in the outpatient clinic.

Collaborators and Investigators

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

Sponsor

Gyeongsang National University Hospital

Collaborators

National Cancer Center, Korea

Investigators

  • Principal Investigator: Sang-Ho Jeong, MD, Gyeongsang National University Changwon Hospital

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 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wecare2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

The study was finished, the data can available

IPD Sharing Access Criteria

Fore researcher, not for business model

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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