Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation

NCT06590285 | Recruiting

• 1 other identifier: IRB-24-8378
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GVHD; Bone Marrow Transplant Complications

Outcome Measures

Primary Outcomes (1)

• Objective Sleep Measurement

  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.

  Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT)

Secondary Outcomes (2)

• Objective activity measurement

  Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT).

• Subjective sleep quality

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

Other Outcomes (1)

• Incidence of acute GVHD

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

Study Arms (2)

Standard of Care Monitoring

NO INTERVENTION

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

App-based Educational Intervention

EXPERIMENTAL

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).

Behavioral: App-based Educational Intervention

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.

App-based Educational Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Failed prior alloHSCT within the past 6 months

Sponsors & Collaborators

• Scripps Health: lead
• Scripps Clinic: collaborator

Study Sites (1)

Scripps Health

San Diego, California, 92037, United States

RECRUITING

Study Officials

• Jake New, MD, PhD

  Scripps Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jake New, MD, PhD

CONTACT

858-784-2701; new.jacob@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to standard of care monitoring or an educational intervention aimed at improving sleep and activity management during the transplantation process.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: April 2, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): November 1, 2033
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)