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

BEHAVIORAL

eHealth Mindfulness-based Music Therapy (eMBMT)

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.

BEHAVIORAL

eHealth Mindfulness Meditation (eMM)

Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.

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)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.