NCT Number: NCT06468618
Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.
Interested in participating?
Request Info9 year–17 year
All sexes
Interventional
Not applicable
Boston Children's Hospital, Boston, Massachusetts, United States
In prior work, investigators conducted a study in which sound and light levels were recorded at one-minute intervals within an inpatient room on the SCT unit at Boston Children's Hospital using noise and light meters. Results showed that pediatric SCT recipients were consistently exposed to disruptive noise and light. Nighttime noise levels always exceeded World Health Organization recommendations for sleep, with recipients regularly exposed to multiple noise spikes associated with night wakings. While light levels were frequently dim enough to be conducive to sleep at night, participants were rarely exposed to light bright enough to preserve a healthy circadian rhythm during the day, which has the potential to dysregulate sleep at night. As a child's circadian rhythms may be affected by evening light to a greater extent than adults, such light spikes may be particularly disruptive to circadian rhythms in pediatric participants. The relatively low and afternoon-skewed daytime light, combined with the brighter than recommended light during the evening and early night, has been associated with longer hospitalizations and higher morbidity among adults.
This is a single-arm pilot study to evaluate the acceptability and feasibility of the DREAMS intervention program in stem cell transplant pediatric participants to help support families during this critical phase in a participant's SCT recovery. The data collected from this study will help understand the practicality of delivering the program to a greater number of participants and conducting clinical research about the program in the setting in which it will be implemented.
The research study procedures include screening for eligibility and surveys.
Participation in this research study is expected to last for about 2 weeks.
It is expected that about 10 children will take part in this research study.
The American Cancer Society is supporting this research study with grant funding.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Primary team declines permission to approach.
A pediatric, circadian health program comprised of an introductory video to sleep experiences for stem cell transplant recipients, strategies to improve sleep, and a Sleep and Circadian Care Kit which includes ear plugs, a white noise machine, an eye mask, a lightbox, and kit instructions. Actigraph, Fitbit, and tablet will be provided to participant and family.
Time frame: Screening (Day -30 to -1)
Defined as the proportion of eligible participants approached by research staff and consent to participate in the study with the cutoff set at ≥30% of eligible participants that are approached and agree to participate.
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
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.
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Feasibility of the DREAMS Program intervention is defined as ≥50% of participants reporting usage of at least one of the Care Kit materials.
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Feasibility of the DREAMS Program intervention is defined as ≥80% of enrolled participants completing the Follow-up Assessment.
Time frame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
An 8-item measure used to assess the extent of a child's poor sleep. The minimum score is 8, and the maximum score is 40. Higher scores indicate worse sleep disturbance outcomes.
Time frame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
An 8-item measure used to assess the extent of the consequences of a child's poor sleep. he minimum score is 8, and the maximum score is 40. Higher scores indicate worse sleep disturbance outcomes.
Time frame: Daily, for 1 week, during the study period.
A self-report of a participant's daily sleep patterns, including bedtime and total sleep duration.
Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Open-ended questions regarding what was liked/disliked about the Care Kit materials.
Contact information is provided by the study sponsor or research team.
Dana-Farber Cancer Institute
Other
Acronym: DREAMS
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