Assessments | Pre-treatment | 1 month from randomization | Follow-up: At 3, 6, 12, 24 months from randomization |
---|---|---|---|
History/physical | Within 2 weeks prior to registration | X | |
Performance status | Baseline | X | |
Neurological exam | Within 1 week prior to registration | X | |
Imaging of the spine (CT scan/bone scan is allowed, MRI preferred) | Within 6 weeks prior to registration | X | |
Numerical rating pain scale and documentation of patient’s pain medicationa | Within 1 week prior to registration | (On the day of treatment) (At home: Daily with cumulative weekly measurements at 1, 2, and 3 weeks; bring to clinic at 1 month) In clinic at 1 month | X |
FACT-G (FA), BPI (QL), EQ-5D (HP) | Baseline | At 3, 6, 12, and 24 months from randomization | |
Adverse event evaluation | X | X |