Table 2.
Trial schedule of enrollment, interventions, and data assessments
| Time point | Screening | Period of adjuvant chemotherapy | Follow-up, months | |||||
|---|---|---|---|---|---|---|---|---|
| −4–0 week | 1 | 3 | 6 | 9 | 12 | … | 36 | |
| Enrollment | ||||||||
| Informed consent | X | |||||||
| Eligibility screen | X | |||||||
| General assessment | ||||||||
| Demographic data | X | |||||||
| Medical history | X | |||||||
| Treatment situation | X | |||||||
| TCM program | ||||||||
| CHM intervention | X | X | X | |||||
| TCM cohort only | X | X | X | X | X | X | X | X |
| Assessment | ||||||||
| FACT-B | X | X | X | |||||
| ECOG | X | X | X | |||||
| BCQ | X | X | ||||||
| MEAD | X | X | ||||||
| Imaging examination (CT, type B ultrasonography, bone scan) | X | X | X | X | X | X | X | |
| Tumor markers (CEA & CA15-3) | X | X | X | X | X | X | X | |
| Safety indicators | X | X | X | X | X | X | X | X |
| Chemotherapy-induced side effect, CTCAE | X | X | X | X | X | X | X | |
| Cohort migration | X | X | X | X | ||||
| Combined medication | X | |||||||
ECOG Eastern Cooperative Oncology Group, FACT-B Functional Assessment of Cancer Therapy-B, BCQ Body Constitution Questionnaire, MEAD Meridian Energy Analysis Device, CT Computed tomography, CEA Carcinoembryonic antigen, CA15-3 Cancer antigen 15-3, CTCAE Common Terminology Criteria for Adverse Events, CHM Chinese herbal medicine, TCM Traditional Chinese medicine