Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation (DREAM-BMT)

Scripps Translational Science Institute

Status: Enrolling

Conditions: Bone Marrow Transplant Complications; GVHD

Treatments: Behavioral: App-based Educational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06590285

IRB-24-8378

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard of Care Monitoring

No Intervention group

Description:

Usual care will be undergoing alloHSCT without any additional sleep-related educational interventions.

App-based Educational Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: App-based Educational Intervention