Trial results for the Sleep ALL Night intervention in children with Acute Lymphoblastic Leukemia were posted on ClinicalTrials.gov on 2025-06-06, showing an acceptability score of 4.40 on a scale.
Background
Acute Lymphoblastic Leukemia (ALL) is the most common childhood cancer. Children undergoing treatment for ALL often experience various side effects, including sleep disturbances and insomnia. Addressing sleep disorders is important for the overall well-being and quality of life of these young patients. Interventions aimed at preventing or managing insomnia can help improve patient comfort and potentially support better treatment adherence and recovery.
Trial design
This completed study enrolled 25 participants with Pediatric Acute Lymphoblastic Leukemia. The trial aimed to assess the acceptability and feasibility of the Sleep ALL Night intervention, a sleep program comprising an action plan tool and a psychoeducational website. The study was conducted as a single-arm trial with no specified phase.
Key results
The trial results provided several key measurements related to the intervention's acceptability and feasibility:
- Enrollment Rate of Participants: The study successfully enrolled 25 participants.
- Acceptability of Intervention Measure Scale Score: The mean score was 4.40 with a Standard Deviation of 0.63 on a scale.
- Intervention Assessment Completion Rate: 22 participants completed the intervention assessment.
What this means
The posted results suggest that the Sleep ALL Night intervention is acceptable and feasible for children with Acute Lymphoblastic Leukemia. The mean acceptability score of 4.40 (SD 0.63) indicates a positive reception of the program by participants. The successful enrollment of 25 participants and an intervention assessment completion rate of 22 participants further support the feasibility of implementing such a sleep intervention. These findings imply that the Sleep ALL Night program could be a practical tool to help address sleep disorders in pediatric ALL patients and facilitate discussions about sleep health with clinical providers.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05866887, titled "Insomnia Prevention in Children With Acute Lymphoblastic Leukemia", were posted on 2025-06-06 on clinicaltrials.gov.