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

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

Observation	Screening	enrolment/baseline	3 months	6 months	12 months	18 months (study termination)	APP (Fort-nightly)	Cancer registry data	Occurrence 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		✓	✓	✓	✓	✓

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)

ISSN: 2055-5784