A registry study on the usefulness of symptom monitoring by ePRO, and status of adverse events and QoL in cancer practice
Not Applicable
- Conditions
- 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.
- Registration Number
- JPRN-UMIN000043975
- Lead Sponsor
- St.Marianna University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in FACT-G baseline and after 3 months in the usual care and ePRO cohorts.
- Secondary Outcome Measures
Name Time Method 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