NCT06590285 · Scripps Health
Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation
(DREAM-BMT)
What this study is about
This randomly assigned, phase I/II, where both patients and doctors know the treatment given study will investigate the effectiveness and safety of an educational sleep intervention vs the usual treatment in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.
View original scientific description
This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.
Interventions
BEHAVIORAL
App-based Educational Intervention
The program's educational content is designed to engage patients in the science of sleep and recovery. Segments like "The Sleep Adventure" demystify complex neurobiological processes in an accessible format, aligning with emerging trends in patient education that focus on engagement and knowledge empowerment. Concurrently, the program's physical activity component is meticulously crafted, offering safe, supportive exercises that correspond with the treatment stages of alloHSCT patients. This aspect draws upon evidence highlighting the importance of sustained physical activity during intensive treatments to enhance overall recovery and quality of life. Additionally, the program comprehensively addresses sleep disturbances, prevalent in HSCT patients, through in-depth exploration and evidence-based, non-pharmacologic management strategies, reflecting the significant impact of sleep quality on patient recovery and long-term health outcomes.
Primary outcome measures
Objective Sleep Measurement
Time frame: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT)
A wearable device will continuously measure objective sleep quality. The outcome will be reported as the average sleep duration (in minutes per day) over the study period. Data will be aggregated for the entire duration of the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female patients aged 18 or older at the time of study informed consent.
- Have 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.
- Patients have access to digital device capable of downloading study app
- Patients able to read study documents and able to complete informed consent within the study app
Exclusion criteria
- Failed prior alloHSCT within the past 6 months
Where
- San Diego, California
Collaborators
Scripps Clinic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations