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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disturbance; Stem Cell Transplant Complications
• Intervention / Treatment: Behavioral: DREAMS Program Video and Care Kit

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucille Lokko, BA; Phone Number: 617-632-6221; Email: lucille_lokko@dfci.harvard.edu
• Study Contact Backup: Name: Eric Zhou, PhD; Phone Number: 617-632-6162

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
      • Principal Investigator: Eric Zhou, PhD
      • Contact: Lucille Lokko; Phone Number: 617-632-6221; Email: lucille_lokko@dfci.harvard.edu
    • Boston, Massachusetts, United States, 02215
      • Boston Children's Hospital
      • Contact: Lucille Lokko, BA; Phone Number: 617-632-6221; Email: lucille_lokko@dfci.harvard.edu
      • Contact: Eric Zhou, PhD; Phone Number: 617-632-6162

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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.
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)

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Eric Zhou, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 24-254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No