This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and self-manage chemotherapy-related adverse effects.
Adults aged 19 years or older
Diagnosed with early or advanced gastric, lung, breast, or colon cancer
Starting first-cycle chemotherapy with a new anticancer agent
Able to use a smartphone without difficulty
Individuals who have difficulty communicating due to cognitive impairment, visual impairment, hearing impairment, or other reasons
Individuals who cannot read, write, or understand Korean
Other individuals deemed inappropriate for participation by the investigators
Parallel
Standardized Telenursing
Other interventionWithin Smart Cancer Care Plus, predefined criteria are applied to trigger standardized telenursing interventions. When patients report symptoms of Grade 3 or higher severity, or when a scheduled weekly symptom report is not submitted within 48 hours of the designated reporting date, a structured telephone counseling session is initiated. This process is intended to ensure timely clinical follow-up, support appropriate self-management, and prevent the progression of unmanaged adverse events.
Smart Cancer Care Plus
Other interventionSmart Cancer Care Plus is a digital platform for patient-reported symptom monitoring and management, developed for individuals receiving chemotherapy. The system enables structured reporting of chemotherapy-related adverse events and provides standardized information regarding the severity grading of symptoms, accompanied by evidence-based self-management strategies. This intervention is intended to promote systematic symptom monitoring and to facilitate timely clinical responses to adverse events.
Quality of life Measured by EORTC QLQ-C30
Quality of life will be assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score for the Global Health Status/Quality of Life scale ranges from 0 to 100, with higher scores indicating better quality of life.
Self-management, which will be assessed using the SECD-6-K
Self-management will be assessed using the Self-Efficacy for Chronic Disease Scale-6 Item, Korean Version (SECD-6-K). The SECD-6-K consists of 6 items, each rated on a 10-point Likert scale (1-10). The total score ranges from 6 to 60, with higher scores indicating better self-management.
Self-rated overall health, which will be assessed using EQ-5D-VAS
Self-rated overall health will be assessed using the EuroQol Visual Analogue Scale (EQ-5D-VAS). Participants rate their overall health on a visual analogue scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better self-rated health.
Adherence to ePROSW
Adherence to ePROSW will be assessed by measuring the frequency of app usage over the entire 6-month study period. App adherence is defined as the total number of times participants accessed and used the ePROSW application during the study period.
Chemotherapy Adherence
Chemotherapy adherence will be evaluated by the percentage of planned chemotherapy completed. Adherence will be calculated as the ratio of the administered dose to the planned dose, expressed as a percentage.
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Ulsan University Hospital
Lead sponsor
National Cancer Center, Korea
Collaborator
Kosin University Gospel Hospital
Collaborator
Gyeongsang National University Hospital
Collaborator
Gachon University Gil Medical Center
Collaborator
