Advanced Breast Cancer, Advanced Colon Cancer, Advanced Gastric Cancer, Advanced Lung Cancer, Early Breast Cancer, Early Colon Cancer, Early Gastric Cancer, Early Lung Cancer
Conditions
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.
Interventions
OTHERStandardized Telenursing
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.
OTHERSmart Cancer 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.
Sponsors
Ulsan University Hospital
National Cancer Center, Korea
Kosin University Gospel Hospital
Gyeongsang National University Hospital
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Healthcare Utilization | 6 months | Healthcare utilization will be assessed by the occurrence of unplanned hospital visits during the study period. |
| 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). |
Countries
South Korea
Contacts
CONTACTMinseon Song, bachelor's degree
CONTACTSomin Joen, bachelor's degree
PRINCIPAL_INVESTIGATORSujin Koh, Doctor of Philoshophy
Ulsan University Hospital
PRINCIPAL_INVESTIGATORKeun Soek Lee, Doctor of Philoshophy
National Cancer Center, Korea
PRINCIPAL_INVESTIGATORSung Hoon Sim, Doctor of Philoshophy
National Cancer Center, Korea
PRINCIPAL_INVESTIGATORJi Hyung Hong, Doctor of Philoshophy
National Cancer Center, Korea
PRINCIPAL_INVESTIGATORSun Jin Sym, Doctor of Philoshophy
Gachon University Gil Medical Center
PRINCIPAL_INVESTIGATORJung Hun Kang, Doctor of Philoshophy
Gyeongsang National University Hospital
PRINCIPAL_INVESTIGATORSeong Hoon Shin, Doctor of Philoshophy
Kosin University Gospel Hospital
Outcome results
None listed