STEPS | Screening | Inclusion Randomisation | V2 Telephone call | V3 Telephone call | V4 Clinical assessmentc | V5 Clinical assessmentc |
---|---|---|---|---|---|---|
Time | J-14 à J-2 | J0 | J7  ± 1 j | J14  ± 1 j | J28 ± 3 j | J56 ± 3 j |
Actions | ||||||
Inclusion and non-inclusion criteria | X | X | Â | Â | Â | Â |
ECG et postural hypotension test | Â | X | Â | Â | Â | Â |
Study information delivery | X | X | Â | Â | Â | Â |
Informed consent | Â | X | Â | Â | Â | Â |
MADRS | X | (X)b | Â | Â | X | X |
HADS-D | X | (X)b | Â | Â | X | X |
QLQ-C30 | Â | X | Â | Â | X | X |
ESAS12-F | Â | X | Â | Â | X | X |
ASEC | Â | X | X | X | X | X |
Factor 1 of the MARS | Â | Â | Â | Â | X | X |
Clinical assessment: weight, blood pressure, Performans Status | Â | X | Â | Â | X | X |
Treatment list | Â | X | Â | Â | X | X |
Sociodemographic dataa | Â | X | Â | Â | Â | Â |
Randomisation | Â | X | Â | Â | Â | Â |
Treatment doses adaptation | Â | X | (X) | X | X | X |
Adhesion to treatment assessment (pill count) | Â | Â | Â | Â | X | X |
Semi-structured interviews | Â | X | Â | Â | Â | X |
Side effects | Â | X | X | X | X | X |