Skip to main content

Table 1 Schedule of enrollment and assessment

From: Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial

 

Baseline (date)

Treatment period (cycle)

Follow-up (months)

Time point

0

1

2

3

4

5

6

7

8

9

12

15

18

21

24

30

36

Enrollment

 Informed consent

√

                

 Eligibility screen

√

                

General assessment

 Disease data

√

                

 Family history

√

                

 Combined diseases

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

 Medical examination

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

 Combination therapy

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

Effectiveness observation

 CT or MRI

√

   

√

   

√

√

√

 

√

 

√

√

√

 Gastroscopy

          

√

   

√

 

√

 Tumor markers

√

 

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

 KPS score

√

 

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

 QLQ-C30

√

   

√

   

√

√

√

√

√

√

√

√

√

 DFS

  

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

Safety observation

 Toxicity events

 

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

 Adverse event

 

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

√

Data evaluation

                

√

Audit medical records

                

√

Ombudsman reviews medical records

                

√

Outcome’s measurement

                

√

  1. CT computed tomography, MRI magnetic resonance imaging, KPS Karnofsky Performance Status, QLQ-30 Quality of Life Questionnaire-30, DFS disease-free survival