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

NCT ID: NCT06468618

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-06
• Study Completion Date: 2026-08-31

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.

Conditions

Stem Cell Transplant Complications; Sleep Disturbance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

DREAMS Program

Enrolled participants and parent(s) will complete:

• Baseline visit with survey
• Standard of care stem cell infusion
• In-clinic visit with introduction to DREAMS program, Sleep and Circadian Care Kit, Actigraph, and Fitbit.
• Follow up survey

Group Type: EXPERIMENTAL

DREAMS Program Video and Care Kit

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Eric Zhou, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lucille Lokko, BA

Role: CONTACT

lucille_lokko@dfci.harvard.edu

617-632-6221

Eric Zhou, PhD

Role: CONTACT

617-632-6162

Facility Contacts

Lucille Lokko, BA

Role: primary

lucille_lokko@dfci.harvard.edu

617-632-6221

Eric Zhou, PhD

Role: backup

617-632-6162

Lucille Lokko

Role: primary

lucille_lokko@dfci.harvard.edu

617-632-6221

References

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.

Reference Type: BACKGROUND

PMID: 37779507 (View on PubMed)

Other Identifiers

24-254

Identifier Type: -

Identifier Source: org_study_id