Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Conditions
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Pediatric Acute Lymphoblastic Leukemia, Leukemia, Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Behavioral: Sleep ALL Night


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep ALL Night<br>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). | Behavioral: Sleep ALL Night<br>* Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate of Participants | 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. | At screening | 
| Acceptability of Intervention Measure Scale Score | 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, on a 5-point scale with options ranging from Completely Agree to Completely Disagree. | At Week 4 | 
| Participant Review Rate of Action Plan | The primary study outcome of feasibility is defined as ≥70% of participants reporting reviewing the study action plan during the study period. | At Week 4 | 
| Psychoeducational Website Access Rate | The primary study outcome of feasibility is defined as ≥50% of participants reporting reviewing the study website during the study period. | At Week 4 | 
| Intervention Assessment Completion Rate | The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment. | Up to 1 month after the conclusion of the study period, up to 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Acute Lymphoblastic Leukemia, Leukemia, Acute Lymphoblastic Leukemia