SEED
Trial status: CompletedProtocol title
Purpose of the study
This observational, feasibility study evaluates the use of patient-reported outcome measures to assess adverse effects of dexamethasone in patients with primary brain tumours, brain metastases, or advanced cancer, alongside clinician-reported toxicities using CTCAE v4. Participants (n=50, including at least 25 with primary brain tumours) and their caregivers will complete symptom assessments at baseline and follow-up. The primary objective is to determine the feasibility of systematically capturing dexamethasone-related toxicities from both patient and clinician perspectives. Secondary outcomes include the nature, frequency, and severity of reported adverse effects, concordance between patient and clinician assessments, and caregiver-reported impacts.
Intervention
Patients and their caregivers complete the Dexamethasone Symptom Questionnaire–Chronic (DSQ-Chronic), the Acetazolamide Toxicity Questionnaire, and the EORTC QLQ-C15-PAL at baseline, week 2, week 4, and week 8. Clinicians perform baseline assessments of toxicity using CTCAE v4 and evaluate functional status via the Karnofsky Performance Status (KPS). Within two weeks of baseline, a structured interview is conducted to assess the face validity of the DSQ-Chronic and Acetazolamide Toxicity Questionnaire
Study Chair
Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: seed.study@sydney.edu.au
Design
Observational Study