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

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.

ClinicalTrials.gov IDNCT07405931

PhaseNA

Enrollment414

SponsorUlsan University Hospital

Age19 Years and older

SexALL

I'm interested View official listing

Conditions studied

Early Gastric Cancer, Advanced Gastric Cancer, Early Lung Cancer, Advanced Lung Cancer, Early Breast Cancer, Advanced Breast Cancer, Early Colon Cancer, Advanced Colon Cancer

About this study

Interventions

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.

Primary outcomes

Quality of life Measured by EORTC QLQ-C30 (12 weeks)

Eligibility information

Inclusion Criteria: * 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 * Willing to provide informed consent to participate in the study Exclusion Criteria: * 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

Study locations

Kosin University Gospel Hospital, Busan, South Korea
National Cancer Center, Korea, Goyang, South Korea
Gachon University Gil Medical Center, Incheon, South Korea
Gyeongsang National University, Jinju, South Korea
Ulsan University Hospital, Ulsan, South Korea

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.