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Table 2 Trial flowchart

From: A phase III randomized-controlled, single-blind trial to improve quality of life with stereotactic body radiotherapy for patients with painful bone metastases (ROBOMET)

  Screening Treatment Follow-up
Simulation During study Year 1
RT 24–48-72 h weekly 1 m Every 3 m
Informed consent x       
Registration of education level, computer experiencea x       
Randomization:
1 × 8.0 Gy
1 × 20.0 Gy
  x      
Numeric Pain Rating Scale x   x x x x x
ECOG performance status x   x    x  
OMED + other analgesics x   x x x x x
Registration of toxicity       x x
Registration of QoLb x      x x
Registration of treatment datac    x     
  1. aEducation level:highest level of education (none, primary school, secundary school or higher education); computer experience: at least once a week access to computer/e-mail (yes or no)
  2. bQoL according to the EORTC QLQ-C30 & BM22 questionnaires; if form is not completed, reason for non-compliance will be documented in compliance form
  3. cSee Section “Treatment compliance”