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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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
Count of Participants Recruited
Recruitment will be measured by the count of participants successfully recruited and randomized into the study.
Time frame: Baseline (T1)
Number of Participants Retained
Participant retention will be examined via the number of participants retained in the study.
Time frame: Up to 18 months
Mean Number of Intervention Sessions that Participants Completed
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.
Time frame: Up to 100 days post-transplant
Satisfaction Scores as Measured by Weekly Rating Satisfaction Score
Scores per item range from 0 to 5. Higher scores indicate more satisfaction.
Time frame: Up to 100 days post-transplant
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
FACT-BMT score range 0-164, with higher scores indicating better quality of life.
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 Repeatable Battery for the Assessment of Neuropsychological Status.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores range from 40-160 with higher scores indicating better cognitive function.
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.
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
Change in anxiety Scores as Measured with the Generalized anxiety disorder (GAD-7)
Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety.
Time frame: Baseline (T1), up to 18 months
Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)
PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression.
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 Immunocompetence as Measured by Cytokines
Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation
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
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