Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06468618

Conditions

Stem Cell Transplant Complications

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

DREAMS Program Video and Care Kit

Study Details

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

Study ID

NCT06468618

Start date

Aug 6, 2024

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

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.

Primary outcome measure

  • Enrollment Rate [ Time Frame: Screening (Day -30 to -1) ]
  • Acceptability of Intervention Measure Scale Score [ Time Frame: At Follow-up Assessment Visit (Day 21, up to Day 28) ]
  • DREAMS Care Kit Usage Rate [ Time Frame: At Follow-up Assessment Visit (Day 21, up to Day 28) ]
  • Intervention Assessment Completion Rate [ Time Frame: At Follow-up Assessment Visit (Day 21, up to Day 28) ]

Central Contacts and Locations

Central contacts

Lucille Lokko, BA

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

Eric Zhou, PhD

617-632-6162

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Lucille Lokko, BA

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

Eric Zhou, PhD

617-632-6162

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Lucille Lokko

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

Principal Investigator:

Eric Zhou, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-07-22.