eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation

Primary outcomes

1. Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)

   Time frame: 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)

2. Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.

   Time frame: Baseline (T1), up to 18 months

   (PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.

3. Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.

   Time frame: Baseline (T1), up to 18 months

   (PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.

4. Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).

   Time frame: Baseline (T1), up to 18 months

   The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.

5. Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index

   Time frame: Baseline (T1), up to 18 months

   Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.

6. Number of Days to Engraftment Measured from Infusion to Engraftment.

   Time frame: 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.

7. Number of Days of Hospitalization Measured from Admission to Engraftment.

   Time frame: 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.

8. Number of Hospital Readmissions after Hospital Discharge

   Time frame: 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.

9. Number of Infections from Hospital Admission

   Time frame: 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.

10. Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)

    Time frame: 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.

11. Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).

    Time frame: Baseline (T1), up to 18 months

    GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.

12. Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised

    Time frame: 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.

13. Change in Serum Cortisol as Measured by ELISA

    Time frame: 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

14. Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay

    Time frame: 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.

15. Change in Immunocompetence as Measured by Thymic Function

    Time frame: Baseline (T1), up to 18 months

    Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.

16. Change in Immunocompetence as Measured by Regulatory T cells

    Time frame: Baseline (T1), up to 18 months

    Regulatory T cells measured as cells/mm^3