gastric cancer
Conditions
Interventions
None listed
Sponsors
St.Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Major Inclusion Criteria: 1. Patients with a pathologically (histologically) confirmed diagnosis of gastric cancer who will be treated with the immune checkpoint inhibitor nivolumab (regardless of line of treatment) 2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 3. Patients at least 20 years of age at the time of informed consent 4. The presence or absence of measurable lesions or evaluable lesions does not matter as an inclusion criterion. 5. Patients who can use an electronic device which can connect to the Internet, at home (including smartphones, tablets, and personal computers). 6. Patients who are scheduled to receive outpatient treatment at the same hospital for at least 3 months.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of adverse events on a reduction in QoL | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactYOSHIKI HORIE
St.Marianna University School of Medicine Department of Clinical Oncology
Outcome results
None listed