C50
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women - with metastatic breast cancer, - who are treated in a participating breast cancer center, - who are insured with one of the following health insurance companies: BARMER, DAK Gesundheit, BKK-VBU*, - who are able to consent, - who are older than 18, - who are receiving drug treatment for metastatic breast cancer, - who have a life expectancy of more than 3 months at enrollment, - who are classified as ECOG 0-2, - who are willing to participate in a weekly, online-based PRO survey, - and who have access to the internet (smartphone, tablet) may be included. *after extension of the legal basis, participation is temporarily possible for patients of other health insurance companies
Exclusion criteria
Exclusion criteria: Patients who do not receive active cancer therapy (comfort care) or who do not meet all of the inclusion criteria are not eligible to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of the study is fatigue at 6 months, measured with a study-specific questionnaire consisting of items from the EORTC CAT item bank via a smartphone app | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are overall survival, unplanned medical consultations, hospitalizations and emergency room visits. | — |
Countries
Germany