Grant Number:	1R34CA301070-01A1 Interpret this number
Primary Investigator:	Raghubar, Kimberly
Organization:	Baylor College Of Medicine
Project Title:	Resolving Sleep Troubles in Childhood Leukemia (REST)
Fiscal Year:	2026

ABSTRACT Acute lymphoblastic leukemia (ALL) is the most common cancer diagnosed in childhood. Although risk-adapted therapy and supportive care have improved survival rates, children who receive chemotherapy continue to experience reduced quality of life, including poor sleep health and fatigue long after treatment. Poor sleep significantly elevates risk for deleterious physical and mental health problems in all children and exacerbates risks in ALL patients. While cognitive-behavioral therapy for pediatric insomnia (CBT-PI) is a ‘gold standard’ intervention, it is severely underutilized in pediatric cancer. Guided by conceptual models of sleep disturbance in pediatric cancer and an intervention mapping framework (IM-ADAPT), we propose to derive and test an adapted, telehealth-delivered CBT-PI protocol, REsolving Sleep Troubles in Childhood Leukemia (REST). The REST protocol will address the unique sleep challenges faced by all children receiving maintenance therapy and the ecologies impacting sleep health among heterogeneous families. To adapt CBT-PI, we will engage in iterative refinements, collaborate with an Expert Panel, gather insights from behavioral health providers, and test the usability of intervention materials. We will then evaluate the preliminary efficacy of REST in a pilot randomized controlled trial (n = 72) comparing REST to a sleep education control group. Participants will be children ages 5-10 years and their caregiver. In addition to feasibility and acceptability, primary outcomes including objective (actigraphy) and subjective (caregiver and child report) sleep patterns, daytime fatigue, and circadian rhythms (diurnal salivary cortisol) will be examined at three timepoints (pre-intervention, post-intervention, and 3-month follow up). We also plan to explore potential predictors of REST’s effects including child and parenting/family characteristics. We hypothesize REST will be feasible and acceptable, and produce greater improvements in sleep, fatigue and circadian rhythms than an education control condition. The proposed project addresses critical gaps in care for children with ALL and will directly inform a larger effectiveness trial.





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