120 Chapter 4 METHODS Study design and participants This prospective study was pursued in the setting of a randomized controlled trial, of which the design was previously reported.22 Additional relevant methods are available as Supplement. In brief, patients between 3 and 18 years, treated according to the Dutch Childhood Oncology Group ALL-11 protocol who received dexamethasone during Medium Risk Group maintenance treatment and their parents were asked to participate. T1 ALL MR patients T2 Evaluation of dexamethasone-induced side effects SDQ SDSC NOSI-K DT-P Support Questionnaires Time (days) 5 Dexamethasone 6mg/m2 Blood samples SDQ SDSC NOSI-K DT-P (thermometer only) Support (short) Figure 1. Study design. Acute lymphoblastic leukemia patients were included during maintenance therapy. Before (T1) and after (T2) five days of dexamethasone treatment peripheral blood samples were collected and validated questionnaires were filled in by parents. At T2 the DT-P consisted of only the thermometer, and the support questionnaire was one additional question. Abbreviations: ALL: acute lymphoblastic leukemia, DT-P: distress thermometer for parents, MR: medium risk, NOSI-K: Nijmeegse Ouderlijke Stress Index Korte versie (shortened Dutch version of the Parenting Stress Index), SDQ: strengths and difficulties questionnaire, SDSC: sleep disturbance scale for children. All included patients were assessed on the first day (T1), before the start of a dexamethasone course, and after five full days (T2) of dexamethasone (6 mg/m2/day). Peripheral blood samples were obtained on both days. Parents were asked to complete questionnaires on both days (Figure 1). All parents and/or patients provided written informed consent to participate. The study was approved by the Medical Ethical Committee of Rotterdam (NL62388.078.17).
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