Table 1.
Study timeline (summary)
| Week | 0 | 12 | 24 | 36 | 48 | |
| Eligibility verification | eCRF | Ο | ||||
| Background | ||||||
| Participant background | eCRF | Ο | ||||
| Psychosocial background | ePRO | ● | ||||
| ECOG PS | eCRF | Ο | ||||
| Adverse events | ||||||
| PRO-CTCAE | ePRO | ● | ● | ● | ● | ● |
| CTCAE v5.0-JCOG | eCRF |
|
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| Laboratory data | eCRF |
|
||||
| Record of the time of the visit | eCRF |
|
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| Records at the time of ePRO confirmation | eCRF |
|
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| Satisfaction (CTSQ) | ePRO | ● | ● | |||
| A questionnaire on ePRO use | ePRO | ● | ||||
| irAE (suspected/confirmed) |
|
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Ο Medical professionals valuation; ● Participant assessment.
CTSQ, Cancer Therapy Satisfaction Questionnaire; ECOG PS, Eastern Collaborative Oncology Group Performance Status; eCRF, electronic case report form; (e)PRO, (electronic) patient-reported outcome; irAE, immune-related adverse event; JCOG, Japan Clinical Oncology Group; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Event.