Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events.
The investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.
In this study, patients diagnosed with lung, head and neck, and esophageal cancers and undergoing chemotherapy will be measured for self-reported side effects using a wearable device to collect biomarkers through an app, and the association between patient quality of life and side effects and biomarkers obtained from the wearable device will be analyzed. On the other hand, blood (EDTA 3cc) for pharmacogenomics testing will be tested once at any point during the study period as an indicator associated with side effects after chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant, Adjuvant Chemotherapy Arm | Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Neoadjuvant, Adjuvant chemotherapy. |
| |
| Palliative Chemotherapy Arm | Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Palliative chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit smartwatch | Other | Patients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Developing artificial intelligence prediction algorism | PRO data and treatment information collected from the wearable are used to evaluate correlations through methods such as linear regression to determine valid variables, utilizing LSTM models, etc. | Through study completion, an average of 30 months |
Not provided
Not provided
Inclusion Criteria:
20 years of age or older
Must have diagnosed with lung, head and neck, or esophageal cancer,
Eastern Cooperative Oncology (ECOG) performance status of 0 to 2.
Patients who have access to a smartphone and can use the mobile app on their own.
Understand the purpose of the study and agree to participate in the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients undergoing chemotherapy after being diagnosed with lung, head and neck, or esophageal cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sehhoon Park, MD | Contact | +82-10-9185-8619 | sehhoon.park@samsung.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Gangnamgu | 06351 | South Korea |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |