eHealth Mindfulness-based Music Therapy for Stem Cell Transplant Patients
This study is testing two eHealth (electronic health) approaches to help patients undergoing stem cell transplantation. One approach is eHealth Mindfulness-based Music Therapy (eMBMT), where you would have 8 sessions with a music therapist, either in person or online. The other is eHealth Mindfulness Meditation (eMM), which involves 8 online sessions you lead yourself. The goal is to see if these interventions can improve your quality of life and reduce symptoms like pain and fatigue. You might be able to join if you are 18 or older, have certain blood cancers (like leukemia or lymphoma), are planning a stem cell transplant, and speak English or Spanish. The study is currently unclear on its recruitment status and plans to enroll 165 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 165 participants.
- What's involved
- Participants will receive 8 sessions of either music therapy or mindfulness meditation, each lasting about 60 minutes. The time between sessions will vary.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health-related quality of life, pain, and fatigue will be measured at the beginning and for up to 18 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Frank J Penedo, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)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.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.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).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 IndexBaseline (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.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.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 DischargeUp 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 Admissionup 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)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).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-RevisedBaseline (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 ELISABaseline (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 ImmunoassayBaseline (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 FunctionBaseline (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 cellsBaseline (T1), up to 18 months
Regulatory T cells measured as cells/mm\^3