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| ID | Type | Description | Link |
|---|---|---|---|
| R03CA259894-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep ALL Night | Experimental | Participants and parents will complete study procedures as outlined:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep ALL Night | Behavioral | Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Zhou, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Kira Bona, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02215 | United States | ||
| Dana-Farber Cancer Institute |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep ALL Night | Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep ALL Night | Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants analyzed (27) is greater than the number enrolled on the study (25) because not all participants were either eligible or interested in study enrollment. | Posted | Count of Participants | Participants | At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period. |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep ALL Night | Single-arm study where participants receive a single meeting to discuss and review study materials regarding sleep health in pediatric ALL patients. |
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Feasibility and acceptability trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maimouna Oumar | Dana-Farber Cancer Institute | 617-632-3000 | maimouna_sy@dfci.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2023 | Apr 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2023 | Apr 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
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| 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. 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. | Posted | Mean | Standard Deviation | score on a scale | At Week 4 |
|
|
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| Primary | Intervention Assessment Completion Rate | The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment. | Number of participants who completed the Post-Intervention Assessment. | Posted | Count of Participants | Participants | Up to 1 month after the conclusion of the study period, up to 8 weeks. |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |