An observational study of symptomatic adverse events and health-related quality of life (HR-QoL) with the use of patient-reported outcome (PRO) in nivolumab therapy for gastric cancer
Not Applicable
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000037433
- Lead Sponsor
- St.Marianna University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Major Exclusion Criteria: 1.Patients who meet any of the following exclusion criteria will be excluded from this study: 2.Patients who concurrently participate in another detailed PRO study. 3.Patients who apparently have difficulty in evaluating their symptoms by themselves due to a mental condition or cognitive impairment. 4.Patients who apparently have difficulty in using an electronic device for data entry due to a physical disability
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of adverse events on a reduction in Qo
- Secondary Outcome Measures
Name Time Method Adverse events at baseline and at 12 weeks of treatment (physician's and patient's assessments). QoL at baseline and at 12 weeks of treatment. Concordance between physician's assessment (NCI-CTCAE, ver.4.0) and patient's assessment (PRO-CTCAE, ver.1.0). Patient's compliance with ePRO entry (e.g., at 4, 8, and 12 weeks).