An Observational Study of Follow-up for Symptomatic Adverse Events Using ePRO in Gastrointestinal Cancer Patients after Starting Oral Anticancer Therapy in Pharmacy
Not Applicable
Recruiting
- Conditions
- colon cancer, gastric cancer, pancreas cancer, biliary tract cancer
- Registration Number
- JPRN-UMIN000046186
- Lead Sponsor
- Hachioji Pharmaceutical Center Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
Not provided
Exclusion Criteria
1. Severe mental illness 2. have cognitive impairment that may affect their ability to complete the questionnaire 3. Native language is not Japanese
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate point estimates and 95% confidence intervals for the rate of the worst symptom-related adverse events at 12 weeks.
- Secondary Outcome Measures
Name Time Method In the ePRO follow-up group, 1. To estimate the point estimate and 95% confidence interval of the rate of symptom-related adverse events at each time point of weeks 1-12 2. To estimate the rate of PRO-CTCAE input, the rate of PRO-CTCAE input results viewed, and the rate of follow-up at each time point of week 1-12, and for 12 weeks (week 1-12) 3. To examine the relationship between the rate of PRO-CTCAE input at 12 weeks (week 1-12) and the ASK-12, CTSQ scores, and MPR In the ePRO follow-up group and the usual follow-up group, 1. To compare the follow-up rate at each time point of week 1-12 and the rate for 12 weeks (week 1-12) 2. To compare the number of tracing reports for 12 weeks (week 1-12) 3. To compare ASK-12 and CTSQ scores and MPR 4. To examine the relationship between the rate of 12-week (week 1-12) follow-up and ASK-12, CTSQ scores, and MPR 5. To summarize follow-up details as descriptive statistics