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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