NCT07405931

Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: Ulsan University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Early Gastric Cancer
• Advanced Gastric Cancer
• Early Lung Cancer
• Advanced Lung Cancer
• Early Breast Cancer
• Advanced Breast Cancer
• Early Colon Cancer
• Advanced Colon Cancer

Interventions

Type	Name	Description
OTHER	Standardized Telenursing	Within 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.
OTHER	Smart Cancer Care Plus	Smart 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.

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

5 sites across 1 country: South Korea