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

February 8, 2026 updated by: Koh Su-Jin, Ulsan University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

414

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Busan, South Korea
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
      • Goyang, South Korea
        • Recruiting
        • National Cancer Center, Korea
        • Contact:
      • Incheon, South Korea
        • Not yet recruiting
        • Gachon University Gil Medical Center
        • Contact:
      • Jinju, South Korea
        • Recruiting
        • Gyeongsang National University
        • Contact:
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care Group
Standard care group is the control group, receiving standard care only without using Smart Cancer Care Plus or standardized telenursing.
Experimental: ePRO Group
ePRO group is the experimental group, using Smart Cancer Care Plus without standardized telenursing.
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.
Other Names:
  • Smart Caner Care Plus
Experimental: ePRO + Telenursing Group
ePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing.
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.
Other Names:
  • Smart Caner Care Plus
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life Measured by EORTC QLQ-C30
Time Frame: 12 weeks
Quality of life will be assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score for the Global Health Status/Quality of Life scale ranges from 0 to 100, with higher scores indicating better quality of life.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-management, which will be assessed using the SECD-6-K
Time Frame: 6 months
Self-management will be assessed using the Self-Efficacy for Chronic Disease Scale-6 Item, Korean Version (SECD-6-K). The SECD-6-K consists of 6 items, each rated on a 10-point Likert scale (1-10). The total score ranges from 6 to 60, with higher scores indicating better self-management.
6 months
Self-rated overall health, which will be assessed using EQ-5D-VAS
Time Frame: 6 months
Self-rated overall health will be assessed using the EuroQol Visual Analogue Scale (EQ-5D-VAS). Participants rate their overall health on a visual analogue scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better self-rated health.
6 months
Adherence to ePROSW
Time Frame: 6 months
Adherence to ePROSW will be assessed by measuring the frequency of app usage over the entire 6-month study period. App adherence is defined as the total number of times participants accessed and used the ePROSW application during the study period.
6 months
Chemotherapy Adherence
Time Frame: 6 months
Chemotherapy adherence will be evaluated by the percentage of planned chemotherapy completed. Adherence will be calculated as the ratio of the administered dose to the planned dose, expressed as a percentage.
6 months
Healthcare Utilization
Time Frame: 6 months
Healthcare utilization will be assessed by the occurrence of unplanned hospital visits during the study period.
6 months
Functional status, which will be assessed using EORTC-QLQ-C30
Time Frame: 6 months
Functional status will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The functional scales include physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. Scores for each scale are linearly transformed to a 0-100 scale, with higher scores indicating better functioning.
6 months
Symptom severity, which will be assessed using EORTC-QLQ-C30
Time Frame: 6 months
Symptom severity will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The symptom scales include fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores for each symptom scale are linearly transformed to a 0-100 scale, with higher scores indicating greater symptom severity (worse outcome).
6 months
Satisfaction, which will be assessed using system usability scale
Time Frame: 6 months
User satisfaction with the system will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The total SUS score is calculated by multiplying the sum of item scores by 2.5, resulting in a range of 0 to 100, where higher scores indicate greater satisfaction (better usability).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulsan University Hospital

Collaborators

National Cancer Center, Korea
Gachon University Gil Medical Center
Gyeongsang National University Hospital
Kosin University Gospel Hospital

Investigators

  • Principal Investigator: Sujin Koh, Doctor of Philoshophy, Ulsan University Hospital
  • Principal Investigator: Keun Soek Lee, Doctor of Philoshophy, National Cancer Center, Korea
  • Principal Investigator: Sung Hoon Sim, Doctor of Philoshophy, National Cancer Center, Korea
  • Principal Investigator: Ji Hyung Hong, Doctor of Philoshophy, National Cancer Center, Korea
  • Principal Investigator: Sun Jin Sym, Doctor of Philoshophy, Gachon University Gil Medical Center
  • Principal Investigator: Jung Hun Kang, Doctor of Philoshophy, Gyeongsang National University Hospital
  • Principal Investigator: Seong Hoon Shin, Doctor of Philoshophy, Kosin University Gospel Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

February 8, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-05-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Gastric Cancer

Clinical Trials on Smart Cancer Care Plus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe