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NCT05866887 | Recruiting | Pediatric Acute Lymphoblastic Leukemia

Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
Sponsor:

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Eric Zhou, PhD

Brief Summary:

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.

Condition or disease

Pediatric Acute Lymphoblastic Leukemia

Leukemia

Acute Lymphoblastic Leukemia

Intervention/treatment

Sleep ALL Night

Phase

Not Applicable

Detailed Description:

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
Estimated Enrollment : 30 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
Actual Study Start Date : September 26, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024
Arm Intervention/treatment

Experimental: 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).

Behavioral: Sleep ALL Night
Ages Eligible for Study: 4 Years to 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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)
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Location Details

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Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02215

Recruiting

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215