Clinical trial NCT06468618: Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
Official title: Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stem Cell Transplant Complications
Sleep Disturbance
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2024-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Primary outcomes:
measure: Enrollment Rate
timeFrame: Screening (Day -30 to -1)
measure: Acceptability of Intervention Measure Scale Score
timeFrame: At Follow-up Assessment Visit (Day 21, up to Day 28)
measure: DREAMS Care Kit Usage Rate
timeFrame: At Follow-up Assessment Visit (Day 21, up to Day 28)
measure: Intervention Assessment Completion Rate
timeFrame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire
timeFrame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire
timeFrame: Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
measure: Sleep Diary
timeFrame: Daily, for 1 week, during the study period.
measure: Program Experience
timeFrame: At Follow-up Assessment Visit (Day 21, up to Day 28)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children&#39;s Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eric Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.