RecruitingNot ApplicableNCT07405931

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


Sponsor

Ulsan University Hospital

Enrollment

414 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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

Interventions

OTHERStandardized 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.

OTHERSmart 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.


Locations(5)

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

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NCT07405931


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