Pediatric Acute Lymphoblastic LeukemiaNCT05866887
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
A study testing Sleep ALL Night in people with Pediatric Acute Lymphoblastic Leukemia and Leukemia, run by Dana-Farber Cancer Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pediatric Acute Lymphoblastic Leukemia, Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Sleep ALL Night
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2023to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Primary team declines permission to approach.
- Children with critical illness (defined as ICU admission)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Children's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Being tested
- Sleep ALL Night
- Keywords
- Pediatric Acute Lymphoblastic Leukemia, Leukemia, Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ALL NightBehavioural
Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website.
| Study group | Role | What they receive |
|---|---|---|
| Sleep ALL Night | Experimental | 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). Receives: Behavioral: Sleep ALL Night |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 month after the conclusion of the study period, up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start26 Sep 2023
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eric Zhou, PhD, Dana-Farber Cancer Institute
- Investigators
- Eric Zhou, PhD, Principal investigator, Dana-Farber Cancer InstituteKira Bona, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866887
- Sponsor's protocol ID
- 22-677
- Other IDs
- R03CA259894-01
- Status last verified
- May 2025
- First submitted
- 10 May 2023
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05866887
- Acronym / sponsor ID
- 22-677
- Keywords
- Pediatric Acute Lymphoblastic Leukemia, Leukemia, Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep ALL Night | Experimental | Behavioral: Sleep ALL NightParticipants 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). |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Primary team declines permission to approach.
- Children with critical illness (defined as ICU admission)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep ALL NightSleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website. | Behavioural | Sleep ALL Night |
Primary outcome
Enrollment Rate of Participants
Time frame: At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.
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.
Acceptability of Intervention Measure Scale Score
Time frame: At Week 4
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.
Intervention Assessment Completion Rate
Time frame: Up to 1 month after the conclusion of the study period, up to 8 weeks.
The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Zhou, PhD principal investigator
Dana-Farber Cancer Institute
Kira Bona, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep ALL Night in people with Pediatric Acute Lymphoblastic Leukemia and Leukemia, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate of Participants (time frame: At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.