Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

The goal of this research study is to understand the acceptability and feasibility of the Sleep ALL Night intervention among children with Acute Lymphoblastic Leukemia (ALL) in hopes of improving the discussion of sleep disorders with clinical providers. The name of the intervention used in this research study is: Sleep ALL Night, which is a sleep intervention program comprised of an action plan tool and psychoeducational website.

This research study is to conduct a single-arm pilot study to determine the acceptability and feasibility of Sleep ALL Night for children with Acute Lymphoblastic Leukemia (ALL). Participation in this research study is expected to last 1 month. It is expected about 30 children will take part in this research study. The National Cancer Institute (NCI) is providing funding for this research study through a grant.

Participants and parents will complete study procedures as outlined: Baseline survey completed by participant parent(s). Introduction to Sleep ALL Night action plan. Review of psychoeducational website and completion of sleep diary. Survey completed by participant parent(s).

Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website.

The primary study outcome of acceptability is defined as the proportion of eligible participants who are approached by research staff who agree to participate in the study, with the cutoff set at ≥30% of eligible participants who are approached agreeing to participate.

The primary study outcome of acceptability is defined as participants reporting an average score of ≥4 ("Agree") on the Acceptability of Intervention Measure scale, a four-item questionnaire assessing the acceptability of an intervention, on a 5-point scale with options ranging from Completely Agree to Completely Disagree.

The primary study outcome of feasibility is defined as ≥70% of participants reporting reviewing the study action plan during the study period.

The primary study outcome of feasibility is defined as ≥50% of participants reporting reviewing the study website during the study period.

The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment.

Inclusion Criteria: Patient in the Maintenance Phase of therapy on or as per DFCI 16-001 and has completed at least two cycles of maintenance therapy to allow adequate recovery from the more intensive Consolidation phase. English or Spanish speaking child and primary caregiver (parent/guardian). Child aged 4-12 years. Exclusion Criteria: Primary team declines permission to approach. Children with critical illness (defined as ICU admission)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.