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Behavioral Intervention

DREAMS Program for Pediatric Stem Cell Transplant Patients (DREAMS Trial)

N/A

Recruiting

Led By Eric Zhou, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient aged 9-17 years

Patient scheduled to receive a stem cell transplant at Boston Children's Hospital

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at follow-up assessment visit (day 21, up to day 28)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help children undergoing stem cell transplants in hospitals by providing them and their families with tools and information to improve their sleep and overall health during their stay.

Who is the study for?

This trial is for children aged 9-17 who are scheduled to receive a stem cell transplant at Boston Children's Hospital and speak English, along with their primary caregiver. It's not open to those whose medical team doesn't allow them to participate.

What is being tested?

The DREAMS program, which includes an educational video and care kit designed to help pediatric SCT patients sleep better during hospital stays, is being tested in this single-arm pilot study.

What are the potential side effects?

Since the intervention involves non-medical tools aimed at improving sleep and circadian health, no direct side effects are expected from the DREAMS program itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 9 and 17 years old.

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I am scheduled for a stem cell transplant at Boston Children's Hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at follow-up assessment visit (day 21, up to day 28)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at follow-up assessment visit (day 21, up to day 28)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at follow-up assessment visit (day 21, up to day 28) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure Scale Score

DREAMS Care Kit Usage Rate

Enrollment Rate

+1 more

Secondary study objectives

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

Program Experience

Sleep Diary

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DREAMS ProgramExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met