Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation

ConditionsGVHD Bone Marrow Transplant Complications

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorScripps Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Failed prior alloHSCT within the past 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Standard of Care MonitoringNo intervention 0 interventions

Group B: App-based Educational InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Objective activity measurement

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.

Time frame

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

Subjective sleep quality

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.

Time frame

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

Other outcomes

Incidence of acute GVHD

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scripps Health

Lead sponsor

Scripps Clinic

Collaborator

Source ClinicalTrials.gov

Apply now