Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
2 other identifiers
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedStudy Start
First participant enrolled
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2024
CompletedResults Posted
Study results publicly available
June 6, 2025
CompletedJune 6, 2025
May 1, 2025
8 months
May 10, 2023
April 17, 2025
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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, 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.
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.
Study Arms (1)
Sleep ALL Night
EXPERIMENTALParticipants 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).
Interventions
Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Primary team declines permission to approach.
- Children with critical illness (defined as ICU admission)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Feasibility and acceptability trial.
Results Point of Contact
- Title
- Maimouna Oumar
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Zhou, PhD
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
Kira Bona, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 10, 2023
First Posted
May 19, 2023
Study Start
September 26, 2023
Primary Completion
June 5, 2024
Study Completion
June 5, 2024
Last Updated
June 6, 2025
Results First Posted
June 6, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu.
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.