About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
eHealth Mindfulness-based Music Therapy (eMBMT)
BehavioralParticipants 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.
eHealth Mindfulness Meditation (eMM)
BehavioralParticipants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.
Treatment groups
Trial outcomes
Primary outcomes
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)
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.
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.
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.
Sponsors and contacts
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University of Miami
Lead sponsor
National Cancer Institute (NCI)
Collaborator