Study period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
 | Enrolment | Allocation | Intervention (Post-allocation) | Follow-up (Post-allocation) | ||||||
Timepoint |  − t1 | 0 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 (Close-out) |
Enrolment | ||||||||||
- Eligibility screen | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Random allocation | Â | X | Â | Â | Â | Â | Â | Â | Â | Â |
Interventions: | ||||||||||
- Pharmaceutical groups | Â | Â | X | X | X | X | Â | Â | Â | Â |
- Placebo group | Â | Â | X | X | X | X | Â | Â | Â | Â |
Assessments: | ||||||||||
- Baseline data collection | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
- Main outcome (fatigue level) | X | Â | X | X | X | X | Â | X | Â | X |
- Secondary outcome (PRO-CTCAE questionnaire for adverse events) | X | Â | X | X | X | X | Â | Â | Â | Â |
- Nurse phone calls | Â | Â | X | X | X | X | Â | X | Â | X |
- In-person visits | X | Â | Â | X | Â | X | Â | Â | Â | Â |