Acute Lymphoblastic Leukemia, Leukemia, Pediatric Acute Lymphoblastic Leukemia
Conditions
Keywords
Pediatric Acute Lymphoblastic Leukemia, Leukemia, Acute Lymphoblastic Leukemia
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.
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.
Interventions
BEHAVIORALSleep ALL Night
Sleep intervention program comprised of a sleep action plan tool and interactive psychoeducation website.
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate of Participants | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Sleep ALL Night |
|---|---|
| Age, Continuous | 5.6 years STANDARD_DEVIATION 1.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: At Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep ALL Night | Acceptability of Intervention Measure Scale Score | 4.40 score on a scale | Standard Deviation 0.63 |
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.
Time frame: At screening, when eligible participants are approached by research staff. Recruitment occurred over a 5-month period.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sleep ALL Night | Enrollment Rate of Participants | 25 Participants |
Primary
Intervention Assessment Completion Rate
The primary study outcome of feasibility is defined as ≥80% of enrolled participants complete the Post-Intervention Assessment.
Time frame: Up to 1 month after the conclusion of the study period, up to 8 weeks.
Population: Number of participants who completed the Post-Intervention Assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sleep ALL Night | Intervention Assessment Completion Rate | 22 Participants |