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| ID | Type | Description | Link |
|---|---|---|---|
| R33CA263335 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eHealth Mindfulness-based Music Therapy (eMBMT) | Experimental | Participants will be in the MBMT group for 5 months. |
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| eHealth Mindfulness Meditation (eMM) | Experimental | Participants will be in the MM group for 5 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth Mindfulness-based Music Therapy (eMBMT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT) | 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) | 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. | 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. | Baseline (T1), up to 18 months |
| Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE). | The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank J Penedo, PhD | Contact | (305) 284-4290 | fpenedo@miami.edu | |
| Sara E Fleszar-Pavlovic, PhD | Contact | (305) 243-4009 | sarafleszarpavlovic@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank J Penedo, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| eHealth Mindfulness Meditation (eMM) | Behavioral | Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually. |
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| 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. | 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. | 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. | 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. | up to 100 Days Post-Infusion Day |
| Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9) | PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression. | Baseline (T1), up to 18 months |
| Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7). | GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety. | 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. | 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 | Baseline (T1), up to 18 months |
| Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay | 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. | 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. | Baseline (T1), up to 18 months |
| Change in Immunocompetence as Measured by Regulatory T cells | Regulatory T cells measured as cells/mm^3 | Baseline (T1), up to 18 months |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
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