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Recruiting NCT07405931

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

No phase Interventional Early Gastric Cancer Advanced Gastric Cancer Early Lung Cancer Advanced Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standardized Telenursing, Smart Cancer Care Plus.
Who it may be relevant to
Registry conditions: Early Gastric Cancer, Advanced Gastric Cancer, Early Lung Cancer, Advanced Lung Cancer. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 even

Primary outcome measures

  • Quality of life Measured by EORTC QLQ-C30 [Time frame: 12 weeks]
Secondary outcome measures (8)
  • Self-management, which will be assessed using the SECD-6-K [Time frame: 6 months]
  • Self-rated overall health, which will be assessed using EQ-5D-VAS [Time frame: 6 months]
  • Adherence to ePROSW [Time frame: 6 months]
  • Chemotherapy Adherence [Time frame: 6 months]
  • Healthcare Utilization [Time frame: 6 months]
  • Functional status, which will be assessed using EORTC-QLQ-C30 [Time frame: 6 months]
  • Symptom severity, which will be assessed using EORTC-QLQ-C30 [Time frame: 6 months]
  • Satisfaction, which will be assessed using system usability scale [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

South Korea · 5 centers
  • Kosin University Gospel Hospital — Busan
  • National Cancer Center, Korea — Goyang
  • Gachon University Gil Medical Center — Incheon
  • Gyeongsang National University — Jinju
  • Ulsan University Hospital — Ulsan

Identifiers

NCT: NCT07405931 · 2025-05-022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗