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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
414
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 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.
Kosin University Gospel Hospital
Busan, South Korea
RECRUITINGNational Cancer Center, Korea
Goyang, South Korea
RECRUITINGGachon University Gil Medical Center
Incheon, South Korea
NOT_YET_RECRUITINGGyeongsang National University
Jinju, South Korea
RECRUITINGUlsan University Hospital
Ulsan, South Korea
RECRUITINGQuality 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.
Time frame: 12 weeks
Self-management, which will be assessed using the SECD-6-K
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.
Time frame: 6 months
Self-rated overall health, which will be assessed using EQ-5D-VAS
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.
Time frame: 6 months
Adherence to ePROSW
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.
Time frame: 6 months
Chemotherapy Adherence
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.
Time frame: 6 months
Healthcare Utilization
Healthcare utilization will be assessed by the occurrence of unplanned hospital visits during the study period.
Time frame: 6 months
Functional status, which will be assessed using EORTC-QLQ-C30
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.
Time frame: 6 months
Symptom severity, which will be assessed using EORTC-QLQ-C30
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).
Time frame: 6 months
Satisfaction, which will be assessed using system usability scale
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).
Time frame: 6 months
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