Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Dana-Farber Cancer Institute25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pediatric Acute Lymphoblastic Leukemia Leukemia Acute Lymphoblastic Leukemia

Interventions

Sleep ALL NightBEHAVIORAL

Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

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)

Locations (2)

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.

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. 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.

Time frame: 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.

Time frame: Up to 1 month after the conclusion of the study period, up to 8 weeks.

Data from ClinicalTrials.gov

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