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Table 1 SPIRIT schedule of enrollment, interventions, and assessments

From: Effectiveness of structured psycho-oncological counseling for relatives of lung cancer patients based on the CALM approach—study protocol of a randomized controlled trial

 

Study period

Enrollment

Baseline

Allocation

Post-allocation

Time point

 − t0

t0

  

t1

Enrollment

Eligibility screen

X

    

Informed consent

X

    

Randomization

  

X

  

Interventions

Intervention: CALM

     

Control: usual care

     

Assessments

Relatives

 GAD-7

 

X

  

X

 PHQ-9

 

X

  

X

 DT

 

X

  

X

 SNCS

 

X

  

X

 CQOLC

 

X

  

X

 Sociodemographic data

 

X

   

Patients

 GAD-7

 

X

  

X

 PHQ-9

 

X

  

X

 DT

 

X

  

X

 Sociodemographic data

 

X

   

 Medical data

 

X

   
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Trials

ISSN: 1745-6215