Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Dana-Farber Cancer Institute

Status: Completed

Conditions: Pediatric Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia; Leukemia

Treatments: Behavioral: Sleep ALL Night

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05866887

R03CA259894-01 (U.S. NIH Grant/Contract)

22-677

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Sleep ALL Night

Experimental group

Description:

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).

Treatment:

Behavioral: Sleep ALL Night