eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)
研究概览
简要总结
The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.
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 a hematologic malignancy (e.g., myelodysplastic syndrome [MDS], acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], or non Hodgkin's Lymphoma [NHL])
- •have a treatment plan for a 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 the prior pilot MBMT R61 phase
- •participated in music therapy or mindfulness programs in the past six months
研究组 & 干预措施
eHealth Mindfulness-based Music Therapy (eMBMT)
Participants will be in the MBMT group for 5 months.
干预措施: eHealth Mindfulness-based Music Therapy (eMBMT) (Behavioral)
eHealth Mindfulness Meditation (eMM)
Participants will be in the MM group for 5 months.
干预措施: eHealth Mindfulness Meditation (eMM) (Behavioral)
结局指标
主要结局
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)
时间窗: Baseline (T1), up to 18 months
Health Related Quality of Life will be measured using the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), a validated 47-item patient-reported outcome measure. It includes the FACT-G core questionnaire (Physical, Social/Family, Emotional, and Functional Well-Being) plus a Bone Marrow Transplant Subscale. Each item is rated on a 5-point Likert scale (0 = not at all; 4 = very much). Subscale scores are summed up to produce a total score, with higher scores indicating better quality of life. Change from baseline will be analyzed using mixed-effects models adjusted for baseline score. FACT-BMT total score (range: 0 to 176)
Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
时间窗: Baseline (T1), up to 18 months
(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.
Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
时间窗: Baseline (T1), up to 18 months
(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.
Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).
时间窗: Baseline (T1), up to 18 months
The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
时间窗: Baseline (T1), up to 18 months
Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.
Number of Days to Engraftment Measured from Infusion to Engraftment.
时间窗: Up to 18 months
To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.
Number of Days of Hospitalization Measured from Admission to Engraftment.
时间窗: Up to 18 months
To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.
Number of Hospital Readmissions after Hospital Discharge
时间窗: Up to 100 days
To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.
Number of Infections from Hospital Admission
时间窗: up to 100 Days Post-Infusion Day
To measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
时间窗: Baseline (T1), up to 18 months
PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.
Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).
时间窗: Baseline (T1), up to 18 months
GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
时间窗: Baseline (T1), up to 18 months
Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.
Change in Serum Cortisol as Measured by ELISA
时间窗: Baseline (T1), up to 18 months
Serum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation
Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay
时间窗: Baseline (T1), up to 18 months
Cytokines levels are measured in pg/mL. Plasma concentrations of 10 cytokines (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α) are measured via the Novex Life Technologies Human Cytokine 10-Plex Kit on the Magpix Luminex platform (ThermoFisher). Assay sensitivity is 0.5-5 pg/mL per analyte with a \>3-log dynamic range. Elevated pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α) and suppressed anti-inflammatory cytokines (e.g., IL-10) are associated with immune dysregulation and chronic stress.
Change in Immunocompetence as Measured by Thymic Function
时间窗: Baseline (T1), up to 18 months
Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
Change in Immunocompetence as Measured by Regulatory T cells
时间窗: Baseline (T1), up to 18 months
Regulatory T cells measured as cells/mm\^3
次要结局
未报告次要终点
研究者
Frank Penedo
Professor
University of Miami
