Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DREAMS Program Video and Care Kit.
- Who it may be relevant to
- Registry conditions: Stem Cell Transplant Complications, Sleep Disturbance. Basic parameters: 9 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Behavioral DREAMS Program Video and Care Kit
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.
Primary outcome measures
- Enrollment Rate [Time frame: Screening (Day -30 to -1)]
- Acceptability of Intervention Measure Scale Score [Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)]
- DREAMS Care Kit Usage Rate [Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)]
- Intervention Assessment Completion Rate [Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)]
Secondary outcome measures (4)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire [Time frame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)]
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire [Time frame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)]
- Sleep Diary [Time frame: Daily, for 1 week, during the study period.]
- Program Experience [Time frame: At Follow-up Assessment Visit (Day 21, up to Day 28)]
Eligibility criteria
Inclusion criteria
- Patient aged 9-17 years.
- Patient scheduled to receive a stem cell transplant at Boston Children's Hospital.
- English speaking child and primary caregiver (parent/guardian).
Exclusion criteria
-Primary team declines permission to approach.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Boston Children's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Publications
- Fidler AL, Waitt J, Lehmann LE, Solet JM, Duffy JF, Gonzalez BD, Beebe DW, Fedele DA, Zhou ES. Sleep and circadian disruptors: Unhealthy noise and light levels for hospitalized pediatric patients. J Hosp Med. 2023 Nov;18(11):999-1003. doi: 10.1002/jhm.13218. Epub 2023 Oct 2. PMID 37779507
Identifiers
NCT: NCT06468618 · 24-254