eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

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 volunteers

Qualifiers

≥ 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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

165 Participants
are divided into 2 treatment groups
Group A: eHealth Mindfulness-based Music Therapy (eMBMT)Experimental treatment 1 intervention
Group B: eHealth Mindfulness Meditation (eMM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline (T1), up to 18 months
2

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.

Time frame
Baseline (T1), up to 18 months
3

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.

Time frame
Baseline (T1), up to 18 months
4

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.

Time frame
Baseline (T1), up to 18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Miami

Lead sponsor

National Cancer Institute (NCI)

Collaborator