Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Stem Cell Transplantation
Conditions
Brief summary
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.
Interventions
BEHAVIORALeHealth 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.
BEHAVIORALeHealth 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.
Sponsors
University of Miami
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age * have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome \[MDS\], acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], or non Hodgkin's Lymphoma \[NHL\]) * have a treatment plan for a hematopoietic stem cell transplant * Speak English or Spanish
Exclusion criteria
* history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months) * severe cognitive impairment (per the short portable mental status questionnaire) * hearing impairment * active alcohol or substance dependence within the past six months * participated in the prior pilot MBMT R61 phase * participated in music therapy or mindfulness programs in the past six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Index | 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. | 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 Discharge | 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 | 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) | 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-Revised | 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 | 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 | 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 | 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 | Baseline (T1), up to 18 months | Regulatory T cells measured as cells/mm\^3 |
Countries
United States
Contacts
CONTACTFrank J Penedo, PhD
CONTACTSara E Fleszar-Pavlovic, PhD
PRINCIPAL_INVESTIGATORFrank J Penedo, PhD
University of Miami
Outcome results
None listed