Clinical trial · Interventional
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
NCT05866887CI-TRIAL-00090693completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Pediatric Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sleep ALL Night | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sleep ALL Night
- 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).
- interventionNames
- Behavioral: Sleep ALL Night
Primary outcomes (3)
- measure
- Enrollment Rate of Participants
- timeFrame
- At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.
- description
- 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.
- measure
- Acceptability of Intervention Measure Scale Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 12 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.