Prospective quality of life analysis of patients with metastatic breast cancer during and after radiotherapy

• Conditions: C79.9; Secondary malignant neoplasm, unspecified site

• Registration Number: DRKS00025331
• Lead Sponsor: niversitätsklinikum Freiburg Klinik für Strahlenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Patients with planned radiation therapy for metastatic breast cancer in the Department of Radiation Medicine at the Freiburg University Medical Center
-Patient with written informed consent

Exclusion Criteria

- Significant neurological or psychiatric illnesses including dementia and seizure disorders
-Medical or psychological condition under which the study director is of the opinion that the study cannot be completed or that adequate information / consent cannot be given
-Non-existent or limited legal capacity

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints of the study are the exploratory recording of patient-reported and physican-reported outcomes in the longitudinal course with baseline before therapy, at the end of therapy, 3, 6 and 12 months and 2 and 5 years after radiotherapy for metastatic breast cancer,as well as the correlation with clinical and pathological parameters as possible influencing factors.The exploratory recording serves to generate hypotheses.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint of the study is the oncological outcome.For this purpose, the findings of the regular radiotherapy and gynecological follow-up as well as the follow-up imaging carried out (usually CT or MRI for indications of loco-regional tumor recurrence or distant metastasis) are checked.This follow-up care for the tumor takes place unchanged according to internal standards, initially after 3 months, then every six months for a total of 2 years, after 2 years annually.