Clinical trial NCT06395935: Wecare Study in Gastric Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Gyeongsang National University Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
First posted: 2024-05-02
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the quality of life in gastric cancer survivor (KOQUSS-40)
timeFrame: at 1, 3, and 6 months after surgery in the outpatient clinic.
Secondary outcomes:
measure: Weight
timeFrame: at 1, 3, and 6 months after surgery in the outpatient clinic.
measure: nutritional index
timeFrame: at 1, 3, and 6 months after surgery in the outpatient clinic.
measure: KOQUSS-40 questionnaire compliance
timeFrame: at 1, 3, and 6 months after surgery in the outpatient clinic.
Other outcomes:
Locations:
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsandnam-do
Study officials:
affiliation: Gyeongsang National University Changwon Hospital
name: Sang-Ho Jeong, MD
role: PRINCIPAL_INVESTIGATOR
References: