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Contemp Clin Trials ; 142: 107577, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38763308

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.


Subject(s)
Hematologic Neoplasms , Hematopoietic Stem Cell Transplantation , Mindfulness , Music Therapy , Quality of Life , Adult , Female , Humans , Male , Anxiety/therapy , Depression/therapy , Feasibility Studies , Hematologic Neoplasms/therapy , Hematologic Neoplasms/psychology , Hematopoietic Stem Cell Transplantation/methods , Hematopoietic Stem Cell Transplantation/psychology , Meditation/methods , Mindfulness/methods , Music Therapy/methods , Pilot Projects , Telemedicine , Transplantation, Homologous , Randomized Controlled Trials as Topic
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