Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients

Sleep Disturbance Clinical Trial

— DREAMS  

Official title:

Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468618
• Other study ID #: 24-254
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: June 2024
• Source: Dana-Farber Cancer Institute
• Contact: Lucille Lokko, BA
• Phone: 617-632-6221
• Email: lucille_lokko[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Stem Cell Transplant Complications

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	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.	Screening (Day -30 to -1)
Primary	Acceptability of Intervention Measure Scale Score	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.	At Follow-up Assessment Visit (Day 21, up to Day 28)
Primary	DREAMS Care Kit Usage Rate	Feasibility of the DREAMS Program intervention is defined as =50% of participants reporting usage of at least one of the Care Kit materials.	At Follow-up Assessment Visit (Day 21, up to Day 28)
Primary	Intervention Assessment Completion Rate	Feasibility of the DREAMS Program intervention is defined as =80% of enrolled participants completing the Follow-up Assessment.	At Follow-up Assessment Visit (Day 21, up to Day 28)
Secondary	PROMIS Sleep Disturbance Questionnaire	An 8-item measure used to assess the extent of a child's poor sleep.	Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
Secondary	PROMIS Sleep-Related Impairment Questionnaire	An 8-item measure used to assess the extent of the consequences of a child's poor sleep.	Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)
Secondary	Sleep Diary	A self-report of a participant's daily sleep patterns, including bedtime and total sleep duration.	Daily, for 1 week, during the study period.
Secondary	Program Experience	Open-ended questions regarding what was liked/disliked about the Care Kit materials.	At Follow-up Assessment Visit (Day 21, up to Day 28)