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NCT Number: NCT06395935

Wecare Study 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.

Recruiting

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gyeongsang National University Hospital

Changwon, Gyeongsandnam-do, 51472, South Korea

Location status: Recruiting

Location contact

Sangho Jeong, MD

CONTACT

[email protected]

+820552143771

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wecare (website)

Other

support feedback of qutionaire & supply educational contents

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight

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

    Weight change

  2. nutritional index

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

    nutritional index change

  3. KOQUSS-40 questionnaire compliance

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

    check the KOQUSS-40 questionnaire compliance

Study contacts

Contact information is provided by the study sponsor or research team.

Sook-Ran Park

CONTACT

[email protected]

+82552142318

Sponsors and collaborators

Lead sponsor

Gyeongsang National University Hospital

Other

Collaborators

  • National Cancer Center, Korea

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 2, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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