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Table 1 Schedule of enrollment, interventions, and assessments (SPIRIT Flow Chart)

From: Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol

 

STUDY PERIOD

 

Enrolment

First Visit

Subsequent Visit

End of Treatment

End of Study

  

V1

Vx

  

Informed consent

x

    

Inclusion/exclusion criteria

x

    

Cohort allocation (sunitinib/pazopanib group)

x

    

Socio-demographic data

x

    

Renal cell carcinoma history

x

    

Prior medication review

x

    

CHES software training

x

    

Delivery of passwords, username and leaflet

x

    

Level of experience with computer tools

x

    

Full physical examination

x

x

x

x

 

Karnofsky index

x

x

x

x

 

Adverse events monitoring (NCI CTCAE V4)

x

x

x

x

 

TKI prescription/dose adaptation

x

x

x

x

 

Concomitant medications

x

x

x

x

 

Supportive care prescription

 

x

x

x

 

Electronic questionnaire EORTC QLQ-C30 + 9 items EORTC Library Item

 

x

x

x

 

Electronic questionnaire EuroQoL EQ-5D-5L

 

x

x

x

 

Need help to fill out questionnaires

 

x

x

x

 

Location (home or hospital) where the patient completes the questionnaire

 

x

x

x

 

Measure of time to fill the questionnaires

 

x

x

x

 

Progression and subsequent anti-cancer treatment if applicable

  

x

x

x

Survival status

 

x

x

x

x

Satisfaction physician questionnaire

    

x

Satisfaction research assistant questionnaire

    

x