Mindfulness Meditation and Sleep Disturbances in Hematopoietic Cell Transplant Patients: Inflammatory Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Participants Enrolling in the Study
研究概览
简要总结
This randomized, controlled study will compare Mindfulness Awareness Practices for Insomnia (MAP-I) to sleep health education (SHE) in subjects receiving autologous hematopoietic cell transplant for multiple myeloma.
详细描述
This randomized controlled study will evaluate the feasibility of implementing a mindfulness intervention targeting inpatient autologous hematopoietic cell transplantation (HCT) recipients (first HCT) with multiple myeloma (MM) and the preliminary efficacy of Mindfulness Awareness Practices for Insomnia (MAP-I) vs. sleep health education (SHE) to improve insomnia outcomes, cellular and transcriptomic markers of inflammation, and insomnia associated behavioral symptoms (depression, fatigue).
Patients enrolled in this study will be randomized to either receive MAP-I or SHE starting 2-4 weeks prior to HCT. Patients will receive two sessions prior to inpatient admission for HCT, and four sessions in the two weeks of hospitalization following HCT, for a total of six intervention (or control) sessions.
Primary Objective: Determine the feasibility of implementing MAP-I among HCT recipients under first autologous HCT for MM.
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
- •≥18 years of age
- •≤ 1 year since initiation of systemic anti-myeloma therapy
- •No prior progression or relapse of myeloma prior to HCT
- •Patient should be eligible to receive melphalan 200 mg/m2 as conditioning regimen
- •Stem cell graft with > 2.0 x10^6 cluster of differentiation 34 cells (CD34+)/kg available for transplant
- •Karnofsky Performance Score (KPS) ≥70
- •Agreeable to random assignment and data collection, including survey completion and blood draws
- •Available to attend the outpatient intervention portion.
- •Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
排除标准
- •Prior autologous HCT
- •Outpatient HCT
- •Presence of coexistent amyloidosis
- •Presence of known Obstructive Sleep Apnea (OSA)
结局指标
主要结局
Number of Participants Enrolling in the Study
时间窗: Up to 2 weeks
This outcome measure is the number of participants signed consent and were enrolled compared to the number of potential participants assessed for eligibility.
Number of Participants Completing Study Procedures
时间窗: 100 days after transplant procedure
This outcome measure is the number of participants completing the required study procedures compared to the number of participants initiating study procedures.
次要结局
未报告次要终点
研究者
Jennifer M. Knight
Assistant Professor
Medical College of Wisconsin