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 pilot test an Electronic Health Mindfulness-based Music Therapy Intervention (eMBMT) intervention to improve health-related quality of life (HRQoL) and reduce symptom burden of patients undergoing allogeneic stem cell transplantation (allo-SCT).
Interventions
BEHAVIORALMindfulness-based Music Therapy (MBMT)
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.
BEHAVIORALMindfulness Meditation (MM)
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 myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or non Hodgkin's Lymphoma (NHL) * have a treatment plan for an allogeneic 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 music therapy or mindfulness programs in the past six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Recruited | Baseline (T1) | Recruitment will be measured by the count of participants successfully enrolled and randomized into the study. |
| Number of Participants Retained | Up to 18 months | Participant retention will be examined via the number of participants retained in the study. |
| Mean Number of Intervention Sessions That Participants Completed | Up to 100 days post-transplant | Participant engagement will be examined via the mean number of intervention sessions completed by participants measured after the 8th (and last) intervention session which is given between 75 and 100 days post-transplant. |
| Satisfaction Scores as Measured by Weekly Rating Satisfaction Score | Up to 100 days post-transplant | Scores per item range from 1 to 5. Higher scores indicate more satisfaction. Weekly satisfaction ratings were averaged across the intervention period to yield a single composite score per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Related Quality of Life Scores as Measured by Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | Baseline (T1), up to 18 months | The Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) assesses health-related quality of life in bone marrow transplant recipients. Scores range from 0-164, with higher scores indicating better quality of life. |
| Change in Pain Interference as Measured by Patient Reported Outcome Measures (PROMIS®) Pain Interference Short Form 8a. | Baseline (T1), up to 18 months | PROMIS® Pain Interference Short Form 8a is scored as a T-score, ranging from 40.7 to 77.0, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater pain interference. |
| Change in Fatigue as Measured by Patient Reported Outcome Measures (PROMIS®) Fatigue Short Form 8a. | Baseline (T1), up to 18 months | PROMIS® Fatigue Short Form 8a is scored as a T-score, ranging from 33.1 to 77.8, with a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate greater fatigue. |
| Change in Cognitive Function Scores as Measured by Fast Cognitive Evaluation | Baseline (T1), up to 18 months | Fast Cognitive Evaluation (FaCE) score range from 0 to 27. Higher score indicates better cognitive function. |
| 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. |
| Change in Anxiety Scores as Measured With the Generalized Anxiety Disorder (GAD-7) | Baseline (T1), up to 18 months | Generalized anxiety disorder (GAD-7) range is 0 to 21; higher score is associated with more severe anxiety. |
| Changes in Depression Scores as Measured With the Patient Health Questionnaire (PHQ-9) | Baseline (T1), up to 18 months | PHQ-9 (patient health questionnaire) score range is from 0 to 27; higher score is associated with more severe depression. |
| 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 Immunocompetence as Measured by Cytokines | Baseline (T1), up to 18 months | Cytokines levels are measured in pg/mL. Any values outside of the normal range are associated with inflammation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrank J. Penedo, PhD
University of Miami
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 14.36 |
| Cancer Type Acute Lymphoblastic Leukemia | 10 Participants |
| Cancer Type Acute Myeloid Leukemia | 21 Participants |
| Cancer Type Hodgkin's Lymphoma | 4 Participants |
| Cancer Type Missing | 1 Participants |
| Cancer Type Myelodysplastic syndrome | 3 Participants |
| Cancer Type Non-Hodgkin's Lymphoma | 9 Participants |
| Cancer Type Other | 4 Participants |
| Marital Status Married/In a relationship | 36 Participants |
| Marital Status Missing | 6 Participants |
| Marital Status Separated/Divorced/Widowed | 7 Participants |
| Marital Status Single/Never married | 12 Participants |
| Primary Language English and Spanish | 3 Participants |
| Primary Language English only | 30 Participants |
| Primary Language Missing | 3 Participants |
| Primary Language Spanish only | 9 Participants |
| Race/Ethnicity, Customized Black/African American | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants |
| Race/Ethnicity, Customized Missing | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 20 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized White/Caucasian | 20 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 16 Participants |
| Stem Cell Transplan Type Allogeneic | 48 Participants |
| Stem Cell Transplan Type Autologous | 11 Participants |
| Stem Cell Transplan Type Missing | 1 Participants |
| Stem Cell Transplan Type No transplant | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
None listed