Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients
1 other identifier
interventional
414
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2025
CompletedFirst Submitted
Initial submission to the registry
January 22, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedFebruary 12, 2026
August 1, 2025
8 months
January 22, 2026
February 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life Measured by EORTC QLQ-C30
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 Outcomes (8)
Self-management, which will be assessed using the SECD-6-K
6 months
Self-rated overall health, which will be assessed using EQ-5D-VAS
6 months
Adherence to ePROSW
6 months
Chemotherapy Adherence
6 months
Healthcare Utilization
6 months
- +3 more secondary outcomes
Study Arms (3)
Standard Care Group
NO INTERVENTIONStandard care group is the control group, receiving standard care only without using Smart Cancer Care Plus or standardized telenursing.
ePRO Group
EXPERIMENTALePRO group is the experimental group, using Smart Cancer Care Plus without standardized telenursing.
ePRO + Telenursing Group
EXPERIMENTALePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Center, Koreacollaborator
- Kosin University Gospel Hospitalcollaborator
- Gyeongsang National University Hospitalcollaborator
- Gachon University Gil Medical Centercollaborator
- Ulsan University Hospitallead
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 22, 2026
First Posted
February 12, 2026
Study Start
July 9, 2025
Primary Completion
March 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 12, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF