Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation

Part of paid clinical trials in San Diego, California.

Sponsor
Scripps Health
Study ID
NCT06590285
Status
Recruiting
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Conditions

  • Bone Marrow Transplant Complications
  • GVHD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • App-based Educational Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 2, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2031
Completion
Nov 1, 2033

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Standard of Care Monitoring
    Usual care will be undergoing alloHSCT without any additional sleep-related educational interventions.
  • Experimental: App-based Educational Intervention
    The intervention is a pioneering, evidence-based educational program designed to optimize sleep and physical activity outcomes in patients undergoing allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT).

Primary Outcome Measure

Objective Sleep Measurement [ Time Frame: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps HealthSan DiegoCalifornia92037
Jake New
[email protected]
858-554-8788

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