Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-26

Study Completion Date

2024-06-05

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.

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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.

Conditions

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Pediatric Acute Lymphoblastic Leukemia Leukemia Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sleep ALL Night

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).

Group Type EXPERIMENTAL

Sleep ALL Night

Intervention Type BEHAVIORAL

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

Interventions

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Sleep ALL Night

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

Intervention Type BEHAVIORAL

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.