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eHealth mindfulness-based music therapy for patients undergoing allogeneic hematopoietic stem cell transplantation: A pilot randomized controlled trial protocol.

Sara E Fleszar-Pavlovic, Blanca Noriega Esquives, Arianna E Brito, Ann Marie Sia, Mary Adelyn Kauffman, Maria Lopes, Patricia I Moreno, Tulay Koru‐Sengul, Rui Gong, Trent Wang, Eric D Wieder, Maria Rueda-Lara, Michael H. Antoni, Krishna Komanduri, Teresa Lesiuk, Frank J Penedo

Contemporary Clinical Trials July 2024 DOI: 10.1016/j.cct.2024.107577 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial protocol Peer reviewed
Sample size 60
Population Patients with a hematologic malignancy undergoing allogeneic stem cell transplantation
Intervention Mindfulness meditation (eMM)
Duration Eight 60-minute sessions; assessments at baseline, pre-infusion, and post-engraftment
Topics Meditation
Keywords Bone marrow transplant Hematologic malignancy Mindfulness-based music therapy
Key findings The protocol proposes a pilot randomized trial to test whether eHealth-based mindfulness-based music therapy (eMBMT) is feasible and acceptable and improves health-related quality of life, symptom burden, and clinical markers of disease activity in patients undergoing allogeneic stem cell transplantation, compared with eHealth-based mindfulness meditation. It also aims to examine whether improvements are mediated by psychosocial and physiological adaptation, including systemic inflammation and immune recovery.

Abstract

Allogeneic stem cell transplantation (allo-SCT) is the preferred therapy for patients with high-risk or relapsed hematologic malignancies, but may be complicated by psychological distress (e.g., depression, anxiety) and symptom burden (e.g., fatigue, pain). Mindfulness-based music therapy (MBMT), a relatively novel integrative medicine intervention that draws from mindfulness and music therapy principles, has shown promise in improving psychosocial outcomes and symptom burden in cancer patients. We outline an eHealth-based MBMT (eMBMT) intervention protocol examining: (1) feasibility, acceptability, and intended effects of eMBMT in improving HRQOL, symptom burden, and clinical markers of disease activity (e.g., infections), and (2) the extent to which eMBMT music therapy component-associated improvements in HRQOL, symptom burden, and disease activity are mediated by improvements in psychosocial and physiological (e.g., systemic inflammation, immune recovery) adaptation. Participants (n = 60) with a hematologic malignancy undergoing allo-SCT will be randomized to receive eMBMT or an eHealth-based mindfulness meditation (eMM) intervention. eMBMT includes eight 60-min sessions facilitated by a music therapist focusing on mindfulness and music therapy. eMM includes eight 60-min self-led MM practices. Feasibility, acceptability, HRQOL, symptom burden, disease activity, and mediation effects of psychosocial and physiological adaptation will be assessed at baseline, pre-infusion, and post-engraftment with blood collection at baseline and post-engraftment. The current pilot RCT is the first eMBMT intervention to address the HRQOL and symptom burden of patients who are undergoing allo-SCT. Results will inform a fully powered RCT to establish preliminary efficacy of eMBMT on improvements in HRQOL, symptom burden, and disease activity.

Comparable studies

Other randomized controlled trials on meditation, most cited first.

Study Year Design Participants
Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment 2003 Randomized controlled trial n = 41
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults 2008 Randomized controlled trial n = 139
Short-term meditation training improves attention and self-regulation Undergraduate Chinese students 2007 Randomized controlled trial n = 40
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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