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

NCT06468618 | Recruiting

• 1 other identifier: 24-254
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Stem Cell Transplant Complications; Sleep Disturbance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire

  Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire

  Baseline and Follow-up Assessment Visit (Day 21, up to Day 28)

• Sleep Diary

  Daily, for 1 week, during the study period.

• Program Experience

  At Follow-up Assessment Visit (Day 21, up to Day 28)

Study Arms (1)

DREAMS Program

EXPERIMENTAL

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

Interventions

DREAMS Program Video and Care Kit 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.

DREAMS Program

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Primary team declines permission to approach.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Eric Zhou, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucille Lokko, BA

CONTACT

617-632-6221; lucille_lokko@dfci.harvard.edu

Eric Zhou, PhD

CONTACT

617-632-6162

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)