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

Not Applicable

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00024015
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 924

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary endpoints are overall survival, unplanned medical consultations, hospitalizations and emergency room visits.