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NCT Number: NCT06590285

Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation

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.

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Key information

Conditions

GVHD Bone Marrow Transplant Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Health

San Diego, California, 92037, United States

Location status: Recruiting

Location contact

Jake New

CONTACT

[email protected]

858-554-8788

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Objective activity 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 physical activity. The outcome will be reported as the average activity duration (in minutes per day) over the study period.

  2. Subjective sleep quality

    Time frame: Measurements will occur 12 days prior to alloHSCT, 10 days after alloHSCT and 60 days after alloHSCT

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with measurements taken at 12 days prior to hospitalization for alloHSCT, 10 days after alloHSCT, and 60 days after alloHSCT. The PSQI is a validated questionnaire that includes a combination of Likert-type and open-ended questions, which are converted to scaled scores following the PSQI guidelines. Respondents indicate the frequency of specific sleep difficulties over the past month and rate their overall sleep quality. Scores for each component range from 0 to 3. Scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

Other outcomes

  1. Incidence of acute GVHD

    Time frame: Monitoring will occur from day of alloHSCT to 100 days post alloHSCT.

    The incidence of acute GVHD will be evaluated through clinical assessment by the treating physician. The outcome will be reported as the number of days from alloHSCT to the onset of acute GVHD.

Study contacts

Contact information is provided by the study sponsor or research team.

Jake New, MD, PhD

CONTACT

[email protected]

858-784-2701

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Collaborators

  • Scripps Clinic

Registry information

Official study title

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

Acronym: DREAM-BMT

Important dates

Study start
2026
Primary completion
2031
Study completion
2033
First posted
Sep 19, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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