Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation (DREAM-BMT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Sleep Measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Failed prior alloHSCT within the past 6 months
研究组 & 干预措施
Standard of Care Monitoring
Usual care will be undergoing alloHSCT without any additional sleep-related educational interventions.
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).
干预措施: App-based Educational Intervention (Behavioral)
结局指标
主要结局
Objective Sleep Measurement
时间窗: 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.
次要结局
- 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)
研究者
Jacob New
Principal Investigator
Scripps Health