Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: App-based Educational Intervention.
- Who it may be relevant to
- Registry conditions: GVHD, Bone Marrow Transplant Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation (DREAM-BMT)
Overview
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.
Detailed description
To facilitate rapid randomization and baseline collection of patient samples in the patient's home environment, screening activities and assessment of inclusion and exclusion criteria will begin once the patient is identified as transplant eligible at the bone marrow transplant meeting. The patient will subsequently be contacted by a study investigator to explain the study, including its potential benefits and risks.
Patients meeting all inclusion and exclusion criteria will be randomized 1:1 to receive either educational intervention or standard of care therapy.
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 asp
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)]
Secondary outcome measures (2)
- Objective activity measurement [Time frame: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT).]
- Subjective sleep quality [Time frame: Measurements will occur 12 days prior to alloHSCT, 10 days after alloHSCT and 60 days after alloHSCT]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Scripps Health — San Diego
Identifiers
NCT: NCT06590285 · IRB-24-8378