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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
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 belowSelect...
I am between 9 and 17 years old.
Select...
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of Intervention Measure Scale Score
DREAMS Care Kit Usage Rate
Enrollment Rate
+1 moreSecondary outcome measures
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire
Program Experience
Sleep Diary
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
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Who is running the clinical trial?
American Cancer Society, Inc.OTHER
226 Previous Clinical Trials
110,633 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
353,083 Total Patients Enrolled
Eric Zhou, PhDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
108 Total Patients Enrolled
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