N/A
N=25
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
Pediatric Acute Lymphoblastic Leukemia · Leukemia · Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT05866887 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Enrollment Rate of Participants — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep ALL Night (Behavioral)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment Rate of Participants |
25 | — |
| PRIMARY Acceptability of Intervention Measure Scale Score |
4.40 | — |
| PRIMARY Intervention Assessment Completion Rate |
22 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05866887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.