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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06468618
Status
Recruiting
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Conditions

  • Sleep Disturbance
  • Stem Cell Transplant Complications

Eligibility Criteria

Sex
ALL
Age
9 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 6, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Enrollment Rate [ Time Frame: Screening (Day -30 to -1) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02215
Lucille Lokko, BA
[email protected]
617-632-6221
Eric Zhou, PhD
617-632-6162
Dana-Farber Cancer InstituteBostonMassachusetts02215
Lucille Lokko
[email protected]
617-632-6221
Eric Zhou, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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