eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation
Part of paid clinical trials in Miami, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT07469592
- Status
- Not Yet Recruiting
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Conditions
- Leukemia, Myeloid, Acute
- Lymphoma, Non-Hodgkin
- Myelodysplastic Syndromes
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Stem Cell Transplantation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Mar 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 165 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: eHealth Mindfulness-based Music Therapy (eMBMT)Participants will be in the MBMT group for 5 months.
- Experimental: eHealth Mindfulness Meditation (eMM)Participants will be in the MM group for 5 months.
Primary Outcome Measure
Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT) [ Time Frame: Baseline (T1), up to 18 months ]
Central Contacts
- Frank J Penedo, PhD(305) 284-4290
- Sara E Fleszar-Pavlovic, PhD(305) 243-4009
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | Frank J Penedo, PhD (PRINCIPAL_INVESTIGATOR) |
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