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| Name | Class |
|---|---|
| National Cancer Center, Korea | OTHER_GOV |
| Kosin University Gospel Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Gachon University Gil Medical Center |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Group | No Intervention | Standard care group is the control group, receiving standard care only without using Smart Cancer Care Plus or standardized telenursing. | |
| ePRO Group | Experimental | ePRO group is the experimental group, using Smart Cancer Care Plus without standardized telenursing. |
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| ePRO + Telenursing Group | Experimental | ePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minseon Song, bachelor's degree | Contact | +82522507018 | 9204564@uuh.ulsan.kr | |
| Somin Joen, bachelor's degree | Contact | +82522301417 | 9204648@uuh.ulsan.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sujin Koh, Doctor of Philoshophy | Ulsan University Hospital | Principal Investigator |
| Keun Soek Lee, Doctor of Philoshophy | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gospel Hospital | Recruiting | Busan | South Korea |
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| OTHER |
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| 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. |
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| 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. | 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. | 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. | 6 months |
| Healthcare Utilization | 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 | 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 | 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 | 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 |
| 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 | Principal Investigator |
| National Cancer Center, Korea | Recruiting | Goyang | South Korea |
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| Gachon University Gil Medical Center | Not yet recruiting | Incheon | South Korea |
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| Gyeongsang National University | Recruiting | Jinju | South Korea |
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| Ulsan University Hospital | Recruiting | Ulsan | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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