Background Collecting symptom, function and adverse event (AE) data directly from children and adolescents undergoing cancer care is more comprehensive and accurate than relying solely on their caregivers or clinicians for their interpretations. We developed the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) measurement system with input from children, parents, and clinicians. Here we report how we determined the recommended Ped-PRO-CTCAE item scoring approach. Methods Scoring approaches compared were 1) at the AE attribute (frequency, severity, interference) using ordinal and dichotomous measures, 2) a weighted composite AE item score by AE attribute (0.5 - frequency; 1.0 - severity; 1.5 - interference), and 3) overall number of AEs endorsed. Associations of each AE attribute, AE item score and overall AE score with the PROMIS® Pediatric measures of anxiety, depressive symptoms, and fatigue were examined. The ability of the overall Ped-Pro-CTCAE AE score to identify patients with PROMIS symptom T-scores worse than reference population scores was assessed. Clinician preference for score information display was elicited through interviews. Results The diverse scoring approaches yielded similar outcomes, including positive correlations of the Ped-PRO-CTCAE attributes, AE item score, and the overall AEs score with the PROMIS Pediatric measures. Clinicians preferred the most granular display of scoring information (actual score reported by the child and corresponding descriptive term). Conclusions Although three scoring approaches yielded similar results, we recommend the AE attribute level of one score per Ped-Pro-CTCAE AE attribute for its simplicity of use in clinical care and research.

Background: Childhood acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy. The onset of obesity during childhood ALL has been well established and is associated with inferior survival rates and increased treatment-related toxicities. This pilot study sought to determine if a dietary intervention is feasible and minimizes weight gain during the initial phases of treatment for ALL. Methods: Participants were recruited from four institutions, fluent in English or Spanish, between 5-21 years old, and enrolled within three days of starting induction therapy. Participants were counseled for six months to follow a low glycemic diet. Dietary and anthropometric data were collected at baseline, end of induction, and end of month six (NCT03157323). Results: Twenty-three of 28 participants (82.1%) were evaluable and included in the analysis. Dietary intake of several nutrients targeted by the nutrition intervention declined (sugar, P = 0.003 and glycemic load, P = 0.053). We also observed a persistent increase in total vegetables across each timepoint (P = 0.015) and by the end of the intervention (P = 0.033). Importantly, we did not observe an increase in body mass index z-score during induction or over the six-month intervention period. Most families found the nutrition intervention easy to follow (60%) and affordable (95%) despite simultaneous initiation of treatment for ALL. Conclusions: A six-month nutrition intervention initiated during the initial phase of treatment for childhood ALL is feasible and may prevent weight gain. Our preliminary findings need to be confirmed in a larger clinical trial.