Actively Recruiting
Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation (DREAM-BMT)
Led by Scripps Health · Updated on 2026-04-09
60
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
Sponsors
S
Scripps Health
Lead Sponsor
S
Scripps Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of an educational sleep intervention compared to standard care in adults undergoing allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). This phase I/II randomized, open-label study aims to investigate how this intervention may improve sleep and physical activity outcomes in patients facing bone marrow transplant complications such as GVHD. The trial will enroll 60 patients to assess safety and efficacy. Participants will be randomly assigned to one of two groups: one receiving usual care involving alloHSCT without additional sleep-related education, and the other receiving an app-based educational program focused on sleep science, management of sleep disturbances, and physical activity tailored to alloHSCT treatment stages. The educational content includes accessible explanations of neurobiological processes and safe exercise guidance to support recovery. Throughout the study, participants will have continuous objective monitoring of sleep and physical activity from two weeks before transplant to 100 days post-transplant. Subjective sleep quality will be assessed at specific time points around the transplant. Screening and baseline sample collection start once transplant eligibility is confirmed, and the study involves remote enrollment and app-based data collection to facilitate participation in the patient's home environment.
CONDITIONS
Brief Title
Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 or older at the time of study informed consent
- Plan to undergo alloHSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood
- Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible
- Access to a digital device capable of downloading the study app
- Able to read study documents and complete informed consent within the study app
You will not qualify if you...
- Failed prior alloHSCT within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - From 2 weeks prior to alloHSCT to 100 days post-alloHSCT
Participants receive either the app-based educational intervention focused on sleep and physical activity or standard care during their allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) treatment period.
Continuous use of the study app with scheduled assessments 12 days before, 10 days after, and 60 days after alloHSCT
Trial Site Locations
Total: 1 location
1
Scripps Health
San Diego, California, United States, 92037
Actively Recruiting
Research Team
J
Jake New, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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