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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025331

Enrollment

100

Registered

2021-06-11

Start date

2021-06-14

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

C79.9

Interventions

Group 1: The baseline examinations and surveys are planned on the day of the planning CT for which the patient has to come to the clinic for radiation therapy. The first regular follow-up in our clini

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactRaluca Stoian

Department für Radiologische Diagnostik und Therapie Klinik für Strahlenheilkunde

raluca.stoian@uniklinik-freiburg.de0761 270-94610

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026