What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol

Table 1 Overview of the study events for each participant during the follow-up period

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

^aSocio-demographics: date of birth, marital status, number of children, declared level of autonomy/dependence, professional position, way of life, kind of home support, cancer type, stage of the cancer, prior and current cancer treatments, personal background of psychotropic drugs use, the existence of a psychological or nutritional follow-up (and frequency of it)
^bHADS-D/MADRS: if not available at the time of screening or older than 7 days old
^cClinical assessment: might be performed using teleconsultation if needed

ISSN: 1472-684X