Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Not Applicable

Completed

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

• Registration Number: NCT05866887
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-19
• Study Start: 2023-09-26
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-05
• Results First Submitted: 2025-04-17
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Results First Posted: 2025-06-06
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Enrollment Rate of Participants	At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.	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.
Acceptability of Intervention Measure Scale Score	At Week 4	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. The scale uses a 5-point scale with options ranging from Completely Agree (5) to Completely Disagree (1). The average score of all four items was used as the primary outcome. A higher score indicates greater belief that the intervention was acceptable for the participant.
Intervention Assessment Completion Rate	Up to 1 month after the conclusion of the study period, up to 8 weeks.	The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment.

Trial Locations

Locations (2)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States