Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Count of Participants Recruited
研究概览
简要总结
The goal of this study is to pilot test an Electronic Health Mindfulness-based Music Therapy Intervention (eMBMT) intervention to improve health-related quality of life (HRQoL) and reduce symptom burden of patients undergoing allogeneic stem cell transplantation (allo-SCT).
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
- •have a primary diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or non Hodgkin's Lymphoma (NHL)
- •have a treatment plan for an allogeneic hematopoietic stem cell transplant
- •Speak English or Spanish
排除标准
- •history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months)
- •severe cognitive impairment (per the short portable mental status questionnaire)
- •hearing impairment
- •active alcohol or substance dependence within the past six months
- •participated in music therapy or mindfulness programs in the past six months
研究组 & 干预措施
Mindfulness Meditation (MM)
Participants will be in the MM group for 5 months.
干预措施: Mindfulness Meditation (MM) (Behavioral)
Mindfulness-based Music Therapy (MBMT)
Participants will be in the MBMT group for 5 months.
干预措施: Mindfulness-based Music Therapy (MBMT) (Behavioral)
结局指标
主要结局
Count of Participants Recruited
时间窗: Baseline (T1)
Recruitment will be measured by the count of participants successfully enrolled and randomized into the study.
Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
时间窗: Up to 100 days post-transplant
Scores per item range from 1 to 5. Higher scores indicate more satisfaction. Weekly satisfaction ratings were averaged across the intervention period to yield a single composite score per participant.
Mean Number of Intervention Sessions That Participants Completed
时间窗: Up to 100 days post-transplant
Participant engagement will be examined via the mean number of intervention sessions completed by participants measured after the 8th (and last) intervention session which is given between 75 and 100 days post-transplant.
Number of Participants Retained
时间窗: Up to 18 months
Participant retention will be examined via the number of participants retained in the study.
次要结局
- Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index(Baseline (T1), up to 18 months)
- Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)(Baseline (T1), up to 18 months)
- Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a.(Baseline (T1), up to 18 months)
- Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a.(Baseline (T1), up to 18 months)
- Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation(Baseline (T1), up to 18 months)
- Number of Days to Engraftment Measured From Infusion to Engraftment.(Up to 18 months)
- Number of Days of Hospitalization Measured From Admission to Engraftment.(Up to 18 months)
- Number of Hospital Readmissions After Hospital Discharge(Up to 100 days)
- Number of Infections From Hospital Admission(up to 100 Days Post-Infusion Day)
- Change in Anxiety Scores as Measured With the Generalized Anxiety Disorder (GAD-7)(Baseline (T1), up to 18 months)
- Changes in Depression Scores as Measured With the Patient Health Questionnaire (PHQ-9)(Baseline (T1), up to 18 months)
- Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised(Baseline (T1), up to 18 months)
- Change in Immunocompetence as Measured by Cytokines(Baseline (T1), up to 18 months)
- Change in Serum Cortisol as Measured by ELISA(Baseline (T1), up to 18 months)
研究者
Frank Penedo
Professor
University of Miami