Esophageal cancer, gastric cancer, duodenal cancer, colon cancer, pancreatic cancer, cholangiocarcinoma, soft tissue tumor, GIST, neuroendocrine tumor, neuroendocrine cancer, malignant mesoderma, NSCLC, SCLC, breast cancer, etc.
Conditions
Interventions
None listed
Sponsors
St.Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Usual care cohort Participants will be monitored for symptoms using the conventional methods (eg, using questionnaires such as the so-called "patient diary") that have been used at each facility. 1. Those with a diagnosis of malignant tumor (esophageal cancer, gastric cancer, duodenal cancer, colon cancer, pancreatic cancer, bile duct cancer, soft tumor, GIST, neuroendocrine tumor, neuroendocrine cancer, malignant mesoderma, NSCLC, SCLC, breast cancer, Others) 2. Those planning the first systemic chemotherapy for 3 months or more 3. ECOG Performance Status is 0-2. 4. 20 years and over 5. Expected prognosis of 6 months or more. 6. Those who can obtain written consent. ePRO Monitoring Cohort: Symptom monitoring by ePRO. Patients use electronic devices (smartphones or tablets) to report symptoms from their homes or waiting rooms, and medical professionals refer to the PRO from electronic medical records. On the electronic medical record dashboard monitor, the ePRO information entered by the patient is displayed in different colors according to the severity, and is displayed in association with the treatment information (anticancer drug) of the electronic medical record. We will not create a special procedure manual that defines the specific measures taken by medical staff. It is not a so-called e-alert. 1. Those with a diagnosis of malignant tumor. 2. The primary organ must match the target organ of the implementation level for each facility at that time. 3. Those planning initial systemic chemotherapy for 6 months or longer 4. ECOG Performance Status is 0-2. 5. 20 years and over 6. Expected prognosis of 6 months or more. 7. Those who can obtain written consent.
Exclusion criteria
Exclusion criteria: 1. Patients who find it clearly difficult to input using a touch screen electronic device (with or without assistance from family members, staff, etc.) 2. Patients whose symptom evaluation is clearly difficult due to mental illness or cognitive impairment 3. Participating in other PRO studies that burden ePRO input in this study at the same time 4. Others that the principal investigator deems inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in FACT-G baseline and after 3 months in the usual care and ePRO cohorts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of regular practice cohort and ePRO practice cohort EQ-5D-5L baseline and changes after 6 months Relationship between EQ-5D-5L and FACT-G PRO-CTCAE baseline and changes after 6 months Satisfaction with chemotherapy (CTSQ) 3 months after the start of treatment Cost Recurrence-free survival, survival Frequency of unreserved consultations and emergency hospitalizations Medical practice survey (Analysis by different cancer types, stages, and regimens) Baseline for PRO evaluation (PRO-CTCAE, FACT-G, ECOG-PS) and changes over time for 6 months Frequency of unreserved consultations and emergency hospitalizations Impact of PRO-CTCAE changes on FACT-G Examining the relationship between CTCAE and PRO-CTCAE Differences in changes in FACT-G at baseline and after 6 months at different recall periods of PRO-CTCAE (compare Platform A and Platform B). Expenses associated with adverse events ePRO Compliance Analysis of the elderly | — |
Countries
Japan
Contacts
Public ContactYoshiki Horie
St.Marianna University School of Medicine Department of Clinical Oncology
Outcome results
None listed