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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
165
Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.
Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
University of Miami
Miami, Florida, United States
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)
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)
Time frame: Baseline (T1), up to 18 months
Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.
(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.
Time frame: Baseline (T1), up to 18 months
Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.
(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.
Time frame: Baseline (T1), up to 18 months
Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).
The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.
Time frame: Baseline (T1), up to 18 months
Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.
Time frame: Baseline (T1), up to 18 months
Number of Days to Engraftment Measured from Infusion to Engraftment.
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To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.
Time frame: Up to 18 months
Number of Days of Hospitalization Measured from Admission to Engraftment.
To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.
Time frame: Up to 18 months
Number of Hospital Readmissions after Hospital Discharge
To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.
Time frame: Up to 100 days
Number of Infections from Hospital Admission
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.
Time frame: up to 100 Days Post-Infusion Day
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.
Time frame: Baseline (T1), up to 18 months
Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).
GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.
Time frame: Baseline (T1), up to 18 months
Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised
Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.
Time frame: Baseline (T1), up to 18 months
Change in Serum Cortisol as Measured by ELISA
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
Time frame: Baseline (T1), up to 18 months
Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay
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.
Time frame: Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Thymic Function
Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.
Time frame: Baseline (T1), up to 18 months
Change in Immunocompetence as Measured by Regulatory T cells
Regulatory T cells measured as cells/mm\^3
Time frame: Baseline (T1), up to 18 months