Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

Insomnia Prevention in Children With Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866887
• Other study ID #: 22-677
• Secondary ID: R03CA259894-01
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Dana-Farber Cancer Institute
• Contact: Lucille Lokko
• Phone: 617-682-0623
• Email: lucille_lokko[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• Sleep ALL Night
Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.