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NCT Number: NCT07405931

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

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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Key information

Conditions

Early Gastric Cancer Advanced Breast Cancer Advanced Colon Cancer Advanced Gastric Cancer Advanced Lung Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Early Breast Cancer Early Colon Cancer Early Lung Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kosin University Gospel Hospital, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Healthcare Utilization

    Time frame: 6 months

    Healthcare utilization will be assessed by the occurrence of unplanned hospital visits during the study period.

  6. 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.

  7. 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).

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Minseon Song, bachelor's degree

CONTACT

[email protected]

+82522507018

Somin Joen, bachelor's degree

CONTACT

[email protected]

+82522301417

Sponsors and collaborators

Lead sponsor

Ulsan University Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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