Skip to main content

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”