Wecare Study in Gastric Cancer Survivors

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395935
• Other study ID #: Wecare2024
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: April 2024
• Source: Gyeongsang National University Hospital
• Contact: Sook-Ran Park
• Phone: +82552142318
• Email: sr0218[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: March 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• Wecare (website)
support feedback of qutionaire & supply educational contents

Locations

Country	Name	City	State
Korea, Republic of	Gyeongsang National University Hospital	Changwon	Gyeongsandnam-do

Sponsors (2)

Lead Sponsor	Collaborator
Gyeongsang National University Hospital	National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight	Weight change	at 1, 3, and 6 months after surgery in the outpatient clinic.
Secondary	nutritional index	nutritional index change	at 1, 3, and 6 months after surgery in the outpatient clinic.
Secondary	KOQUSS-40 questionnaire compliance	check the KOQUSS-40 questionnaire compliance	at 1, 3, and 6 months after surgery in the outpatient clinic.