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Table 1 Overview of endpoints, time of data collection for the BRE-4-MED registry concept

From: Development and proof-of-concept of a multicenter, patient-centered cancer registry for breast cancer patients with metastatic disease—the “Breast cancer care for patients with metastatic disease” (BRE-4-MED) registry

ObservationScreeningenrolment/baseline3 months6 months12 months18 months (study termination)APP (Fort-nightly)Cancer registry dataOccurrence of event
Timeframe + 1 day+/− 2 weeks+/− 2 weeks+/− 2 weeks+/− 2 weeks+/− 3 days+/− 1 month 
Eligibility check       
Patient information        
Informed consent        
Endpoints:         
(a) Treatment:
 Physicians questionnaire      
(b) Patient and caregiver:
 Quality of life/health status1   
 Physical functioning2   
 Depression/anxiety3    
 Caregiver burden4     
 Individual patient’s needs5   
 Access to health care services6   
 Physician’s empathy7    
 Vital status, therapy change, progression   
 Socio-demographics    
(3) Treatment framework:
 Living area        
 Health care settings       
Core Data      
Confounders      
Endpoints    
  1. 1EORTC-QLQ-2 (Version 3); 2PROMs (PROMIS, physical function) 4-item scale; 3depression and anxiety (Patient Health Questionnaire-4 (PHQ-4)); 4caregiver burden (Caregiver Reaction Assessment (CRA)); 5patient’s health care needs (i.e., social, informational, psycho-oncological, administrative support); 6access to health care services (i.e., psycho-oncological therapy, self-aid group, medical rehabilitation, palliative care, sports); 7consultation and relational empathy (CARE)