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

NCT07405931 — Not applicable, Recruiting, 414 participants, Ulsan University Hospital

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RegistryNCT07405931
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment414 (Estimated)
SponsorUlsan University Hospital (Other); collaborators: National Cancer Center, Korea, Kosin University Gospel Hospital, Gyeongsang National University Hospital, Gachon University Gil Medical Center
ConditionsEarly Gastric Cancer, Advanced Gastric Cancer, Early Lung Cancer, Advanced Lung Cancer, Early Breast Cancer, Advanced Breast Cancer, Early Colon Cancer, Advanced Colon Cancer
InterventionsStandardized Telenursing, Smart Cancer Care Plus (Other)
Datesstart 2025-07-09, primary completion 2026-03-01 (estimated), completion 2026-09-01 (estimated), first posted 2026-02-12, last updated 2026-02-12
Locations5 sites in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Early Gastric Cancer All trials for Advanced Gastric Cancer All trials of Standardized Telenursing All trials of Smart Cancer Care Plus

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Standard Care GroupNo interventionStandard care group is the control group, receiving standard care only without using Smart Cancer Care Plus or standardized telenursing.
ePRO GroupExperimentalOther: Smart Cancer Care PlusePRO group is the experimental group, using Smart Cancer Care Plus without standardized telenursing.
ePRO + Telenursing GroupExperimentalOther: Standardized Telenursing; Other: Smart Cancer Care PlusePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing.
  • Standardized Telenursing (Other): 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.
  • Smart Cancer Care Plus (Other), also known as Smart Caner 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.

+Outcome measures

Primary outcomes

  • Quality of life Measured by EORTC QLQ-C30 [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.

Secondary outcomes

  • Self-management, which will be assessed using the SECD-6-K [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.
  • Self-rated overall health, which will be assessed using EQ-5D-VAS [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.
  • Adherence to ePROSW [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.
  • Chemotherapy Adherence [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.
  • Healthcare Utilization [6 months]: Healthcare utilization will be assessed by the occurrence of unplanned hospital visits during the study period.
  • Functional status, which will be assessed using EORTC-QLQ-C30 [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.
  • Symptom severity, which will be assessed using EORTC-QLQ-C30 [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).
  • Satisfaction, which will be assessed using system usability scale [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).

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (5)

FacilityCityCountryStatus
Kosin University Gospel HospitalBusanSouth KoreaRecruiting
National Cancer Center, KoreaGoyangSouth KoreaRecruiting
Gachon University Gil Medical CenterIncheonSouth KoreaNot yet recruiting
Gyeongsang National UniversityJinjuSouth KoreaRecruiting
Ulsan University HospitalUlsanSouth KoreaRecruiting

+Investigators