Table 1 Study plan detailing the procedures

Study period

Visit

V1

V2

V3 (post-operation)

V4

V5

V7

V8

Visit day

− 1 (± 2 days)

Randomization/baseline

1  (± 1 day)

3  (± 1 day)

5  (± 1 day)

7 (± 1 day)

14 (± 3 days)

Screening/demography

 Written informed consent

√

 Inclusion/exclusion criteria

√

 Demographics

√

 Physical examination, height, and weight

√

 Medical/current conditions

√

 ECOG (Eastern Cooperative Oncology Group)

√

 CCI (Charlson Comorbidity Index)

√

Intervention

 Consultation, education, drug guidance, telephone consultation with the psychiatrists

√

√

√

√

√

 MDASI-LC (ePRO)

√

√

√

√

√

√

 QLQ-C30 (paper)

√

 Adverse events

√

√

√

√

√

√

√

Clinical characteristics

 Surgical procedure, surgical approach, extent of surgery, stage, postoperative length of stay, postoperative chemotherapy

√

Study period

Visit

V10

V11

V12

V13

V14

V15

V16

V17

V18

Study day

29 (± 3 days)

36 (± 3 days)

43 (± 3 days)

50 (± 3 days)

57 (± 3 days)

64 (± 3 days)

71 (± 3 days)

78 (± 3 days)

86 (± 3 days)

Screening/demography/baseline

 Written informed consent

 Inclusion/exclusion criteria

Demographics

 Physical examination, height, and weight

 Medical/current conditions

 ECOG (Eastern Cooperative Oncology Group)

 CCI (Charlson Comorbidity Index)

Intervention

 Consultation, education, drug guidance

√

√

√

√

√

√

√

√

√

 MDASI-LC (ePRO)

√

√

√

√

√

√

√

√

√

 QLQ-C30 (paper)

√

√

 Adverse events

√

√

√

√

√

√

√

√

√

Clinical characteristics

 Surgical procedure, surgical approach, extent of surgery, stage, postoperative length of stay, postoperative chemotherapy