195 Hydrocortisone as an intervention (RCT) 6 SUPPLEMENTAL METHODS Acute lymphoblastic leukemia treatment Only patients with medium risk acute lymphoblastic leukemia (ALL) were eligible for our study since standard risk and high risk patients do not receive regular courses of dexamethasone. The ALL-11 medium risk group maintenance phase in which our research was conducted contains 28 three week treatment cycles. Patients could start with the study after cessation of doxorubicin, which is given on the first day of the first four treatment cycles. Patients could be included in the study at any given time, that is, some patients started directly after cessation of doxorubicin (beginning of maintenance treatment) and some patients started later or at the end of maintenance treatment. Dexamethasone 6 mg/m2/day was given during 5 consecutive days at the beginning of each treatment cycle. Patients also received vincristine once every three weeks, methotrexate once per week and 6-mercaptopurine once per day. A subgroup of patients also received asparaginase once every three weeks. Sample size calculation A sample size of 23 pairs with a correlation equal to 0 achieves 79% power to detect a difference of -5,2 between the null hypothesis mean difference of 0 and the actual mean difference of -5,2 at the 5% significance level (alpha) using a two-sided Wilcoxon Signed-Rank Test. These results were based on 3000 Monte Carlo samples from the null distribution: Normal with mean 3.4 and standard deviation 5.4 and the alternative distribution Normal with mean 8.6 and standard deviation equal to 6.3. Power computations were performed with PASS 2020 Power Analysis & Sample Size (https:// www.ncss.com/software/pass/). We included 52 patients in our RCT and therefore met the aim of including 50 individual patients. Objective sleep measurement with ActiGraph Patients (sometimes through their parents) were instructed to wear the ActiGraph non-stop for seven consecutive days twice (during hydrocortisone and placebo). The ActiGraph could only be removed for showering or swimming. The parent kept an additional sleep-diary to document bedtimes, time of awakening, and removal periods. Actigraphy data were processed using ActiLife version 6.13.3. The Sadeh algorithm was used to generate sleep outcomes.40 Incomplete or invalid data were removed from further analyses and only wearing periods with 4 or more valid nights were assessed.41,42
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