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

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

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.

Sponsors & Collaborators

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Kosin University Gospel Hospital

  collaborator OTHER

• Gyeongsang National University Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Ulsan University Hospital

  lead OTHER

Principal Investigators

• Sujin Koh, Doctor of Philoshophy · Ulsan University Hospital

• Keun Soek Lee, Doctor of Philoshophy · National Cancer Center, Korea

• Sung Hoon Sim, Doctor of Philoshophy · National Cancer Center, Korea

• Ji Hyung Hong, Doctor of Philoshophy · National Cancer Center, Korea

• Sun Jin Sym, Doctor of Philoshophy · Gachon University Gil Medical Center

• Jung Hun Kang, Doctor of Philoshophy · Gyeongsang National University Hospital

• Seong Hoon Shin, Doctor of Philoshophy · Kosin University Gospel Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-09

Primary Completion

2026-03-31

Completion

2026-09-30

Countries

• South Korea

Study Locations