Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation
- Conditions
- GVHDBone Marrow Transplant Complications
- Interventions
- Behavioral: App-based Educational Intervention
- Registration Number
- NCT06590285
- Lead Sponsor
- Scripps Translational Science Institute
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- Failed prior alloHSCT within the past 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description App-based Educational Intervention 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 Measures
Name Time Method Objective Sleep Measurement 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 Outcome Measures
Name Time Method Objective activity measurement 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.
Subjective sleep quality 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.
Trial Locations
- Locations (1)
Scripps Health
🇺🇸San Diego, California, United States