Acute lymphoblastic leukemia (ALL) is the most common childhood cancer.¹ Although more than 95% of children with ALL enter remission after a 4-week induction, approximately 20% relapse within 5 years.¹ Second-line therapies are toxic, and salvage is poor.² Durable first clinical remission is desirable and requires a prolonged maintenance phase with daily self-administered oral mercaptopurine. Low mercaptopurine systemic exposure increases relapse risk.^3-5 Patient adherence to mercaptopurine is a primary determinant of mercaptopurine systemic exposure.⁶ Adherence to medication is a process by which patients take their medication as prescribed and typically consists of 3 phases: initiation, implementation, and discontinuation.^7,8 In the present study and our prior studies,⁸ we focus on the implementation phase of mercaptopurine adherence, in which patients have initiated but have not yet discontinued mercaptopurine. In a previous Children’s Oncology Group (COG) study (AALL03N1), we measured mercaptopurine adherence electronically in children with ALL entering maintenance during the first clinical remission, using the Medication Event Monitoring System (MEMS) TrackCap device (Aprex Corp).^6,9,10 Poor mercaptopurine adherence (mean adherence rates, <90% to 95%) was associated with a 2.5- to 3.9-fold higher relapse risk; up to 59% of ALL relapses were attributable to poor mercaptopurine adherence.^6,9,10 The most common reason for missing mercaptopurine was forgetfulness⁹; adherent patients and parents endorsed parental vigilance as a strategy to overcome forgetfulness.¹¹ Given the critical need to improve mercaptopurine adherence in children with ALL, we conducted a randomized clinical trial (COG ACCL1033) in which children with ALL receiving mercaptopurine maintenance were randomly assigned to receive either education alone or a comprehensive adherence-enhancing intervention in addition to education. We wished to test the hypothesis that the adherence-enhancing intervention consisting of education and daily text message reminders to prompt directly supervised therapy (DST) would result in a higher proportion of patients with mercaptopurine adherence rates 95% or higher compared with education alone.

BACKGROUND: Pediatric participants on phase 1 or phase 2 clinical trials for incurable cancer are at risk of experiencing toxicities (adverse events [AEs]) related to trial participation. Multiple AEs are subjective; thus, the real impact of trial treatment cannot be known unless patient subjective reports are solicited.METHODS: The authors assessed the feasibility and acceptability of soliciting symptom, function, and quality of life (QOL) reports from participants aged 8 to 18 years who were enrolled on phase 1/2 clinical trials at 4 cancer centers during the first course of chemotherapy. The authors also assessed the reliability and validity of 6 self‐report Patient‐Reported Outcomes Measurement Information System (PROMIS) pediatric measures and 4 open‐ended interview questions at 2 time points (at the time of trial enrollment [T1] and 3 to 4 weeks later [T2]).RESULTS: The enrollment rate of 75.9% (20 participants) exceeded the feasibility criterion, and missingness of measures by person, measure, and items at T1 and T2 were lower than the acceptability criteria. New QOL themes were limited to the impact of treatment on families and being away from home, family, and friends for treatment. All but one measure at T1 met the reliability criterion and all measures did so at T2. Validity support was limited however because as theorized, mobility decreased and fatigue increased as AEs increased.CONCLUSIONS: Soliciting and documenting symptom, function, and QOL reports from patients aged 8 to 18 years who are enrolled on a phase 1/2 clinical trial is feasible and acceptable to participants, particularly when embedded in trials. Reliable and valid findings can result, making patient self‐reported outcomes a possible new trial endpoint. Cancer 2017;123:3799–3806. © 2017 American Cancer Society

Integrative Therapies (IT), otherwise known as Complementary and Alternative Medicine, are widely used among pediatric oncology patients, despite a paucity of available evidence. This review summarizes surveys that describe the prevalence of IT use by pediatric oncology patients, both during therapy and in survivorship, as well as the modalities being used. Additionally, the evidence that exists for specific treatments that appear to be efficacious in controlling specific symptoms is described. Finally, there are recommendations for practitioners on how to best counsel patients about IT use.