5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment

Table 4 SPIRIT diagram (Standard Protocol Items: Recommendations for Interventional Trials)

Study period
	Enrolment	Allocation	Intervention (Post-allocation)				Follow-up (Post-allocation)
Timepoint	*− t*₁	0	*Week 1*	*Week 2*	*Week 3*	*Week 4*	*Week 5*	*Week 6*	*Week 7*	*Week 8* *(Close-out)*
Enrolment
- Eligibility screen	X
- Informed consent	X
*- Random allocation*		X
Interventions:
- Pharmaceutical groups			X	X	X	X
- Placebo group			X	X	X	X
Assessments:
- Baseline data collection	X
- Main outcome (fatigue level)	X		X	X	X	X		X		X
- Secondary outcome (PRO-CTCAE questionnaire for adverse events)	X		X	X	X	X
- Nurse phone calls			X	X	X	X		X		X
- In-person visits	X			X		X

Abbreviation: PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events

ISSN: 1745-6215