Wecare Study in Gastric Cancer Survivors

NCT ID: NCT06395935

Last Updated: 2024-10-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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. .

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Wecare (website)

Intervention Type OTHER

support feedback of qutionaire \& supply educational contents

Interventions

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Wecare (website)

support feedback of qutionaire \& supply educational contents

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Gyeongsang National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang-Ho Jeong, MD

Role: PRINCIPAL_INVESTIGATOR

Gyeongsang National University Changwon Hospital

Locations

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Gyeongsang National University Hospital

Changwon, Gyeongsandnam-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sook-Ran Park

Role: CONTACT

+82552142318

Facility Contacts

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Sangho Jeong, MD

Role: primary

+820552143771

Other Identifiers

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Wecare2024

Identifier Type: -

Identifier Source: org_study_id

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