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

TitleeHealth mindfulness-based music therapy for patients undergoing allogeneic hematopoietic stem cell transplantation: A pilot randomized controlled trial protocol.
Publication TypeJournal Article
Year of Publication2024
AuthorsFleszar-Pavlovic SE, Esquives BNoriega, Brito AE, Sia AMarie, Kauffman MAdelyn, Lopes M, Moreno PI, Koru-Sengul T, Gong R, Wang T, Wieder ED, Rueda-Lara M, Antoni M, Komanduri K, Lesiuk T, Penedo FJ
JournalContemp Clin Trials
Volume142
Pagination107577
Date Published2024 Jul
ISSN1559-2030
KeywordsAdult, Anxiety, Depression, Feasibility Studies, Female, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Humans, Male, Meditation, Mindfulness, Music Therapy, Pilot Projects, Quality of Life, Randomized Controlled Trials as Topic, Telemedicine, Transplantation, Homologous
Abstract

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

DOI10.1016/j.cct.2024.107577
Alternate JournalContemp Clin Trials
PubMed ID38763308
PubMed Central IDPMC11244650
Grant ListK01 CA258955 / CA / NCI NIH HHS / United States
R61 CA263335 / CA / NCI NIH HHS / United States
T32 CA251064 / CA / NCI NIH HHS / United States