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PRO B - patient-reported outcomes in breast diseases - New approaches in the care of metastatic breast cancer

PRO B - patient-reported outcomes in breast diseases - New approaches in the care of metastatic breast cancer - PRO B

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024015
Enrollment
1000
Registered
2021-02-15
Start date
2021-05-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: Patients receive a weekly PRO survey via smartphone app which triggers an alarm to the treating breast cancer center in case of worsening values. They will be contacted by their treating ph

Sponsors

Charité - Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime frame
Secondary endpoints are overall survival, unplanned medical consultations, hospitalizations and emergency room visits.

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 7, 2026