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

Recruiting

• Conditions: C71; C79.3; Malignant neoplasm of brain; Secondary malignant neoplasm of brain and cerebral meninges

• Registration Number: DRKS00031480
• Lead Sponsor: Klinik für Strahlentherapie und Radioonkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

- ECOG > 2
- refusal to participate

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>To evaluate discrepancies, the following statistical parameters will be evaluated: ordinal logistic regression analysis, C-statistics (concordance index) and Cohen's kappa.

Secondary Outcome Measures

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