Evaluation of concordance/discrepancy between clinician- and patient-reported outcome in brain irradiation

Evaluation of concordance/discrepancy between clinician- and patient-reported outcome in brain irradiation - NeuroPRO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031480

Enrollment

150

Registered

2023-03-14

Start date

2023-01-01

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

C71 C79.3

Interventions

Group 1: Patients who receive a percutaneous crThe aim of this study is to investigate the agreement between clinician-reported outcomes (CRO) and patient-reported outcomes (PRO) as well as the retros

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - malignant cerebral neoplasm - percutaneous cranial radiotherapy planned - ECOG performance score max. 2 - informed consent

Exclusion criteria

Exclusion criteria: - ECOG > 2 - refusal to participate

Design outcomes

Primary

Measure	Time frame
Primary endpoint: discrepancy between CRO (CTCAE v5.0) and PRO (EORTC QLQ-C30 and BN20) at three different time points (before the first irradiation, after the last irradiation, and at regular radiotherapy follow-up approximately 6 weeks after completion of treatment). To evaluate discrepancies, the following statistical parameters will be evaluated: ordinal logistic regression analysis, C-statistics (concordance index) and Cohen's kappa.	—

Measure

Time frame

Primary endpoint: discrepancy between CRO (CTCAE v5.0) and PRO (EORTC QLQ-C30 and BN20) at three different time points (before the first irradiation, after the last irradiation, and at regular radiotherapy follow-up approximately 6 weeks after completion of treatment). To evaluate discrepancies, the following statistical parameters will be evaluated: ordinal logistic regression analysis, C-statistics (concordance index) and Cohen's kappa.

—

Secondary

Measure	Time frame
Secondary endpoint: prevalence of adverse events in brain irradiation, Decision Regret (Ottawa Decision Regret Scale) after brain irradiation.	—

Countries

Germany

Contacts

Public ContactCas Dejonckheere

Klinik für Strahlentherapie und Radioonkologie

cas.dejonckheere@ukbonn.de0228 287 57000

Outcome results

None listed

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