Music therapy versus cognitive behavioral therapy for anxiety in cancer survivors: A telehealth-based randomized clinical trial.

12003 Background: Anxiety is prevalent, disruptive, and under-treated among cancer survivors. While the pandemic exacerbated the mental health crisis, it also accelerated telehealth adoption, creating opportunities to expand access. Cognitive behavioral therapy (CBT) is the gold standard for anxiety, but not all survivors respond to it, have access, or prefer this option due to stigma. Music therapy (MT) has demonstrated short-term anxiety reduction, but its long-term effectiveness relative to other treatments is unknown. This study evaluated whether MT is noninferior to first-line CBT when both are delivered remotely. Methods: In this randomized clinical trial, English- or Spanish-speaking survivors of any cancer type or stage with anxiety lasting ≥1 month were randomized 1:1 to MT or CBT. Participants received 7 weekly sessions of a standardized protocol via Zoom and were followed for 26 weeks. Co-primary endpoints were Hospital Anxiety and Depression Scale (HADS) anxiety subscale changes at weeks 8 and 26. Secondary outcomes included depression, fatigue, insomnia, pain, cognitive function, and quality of life. Data were analyzed with linear mixed-effects models following intention-to-treat. Assuming 15% attrition and 1-sided p < 0.025, the trial had 80% power to detect noninferiority within a margin of D = 0.35*standard deviations (SDs). The margin was informed by an expected SD of 4.2 and the minimum clinically important difference (MCID) of 1.7 points for the HADS anxiety subscale. Thus, establishing noninferiority would indicate differences between MT and CBT are not clinically meaningful. Results: Among 300 (147 MT; 153 CBT), mean age was 56.9 (SD 13.2) years, 224 (74.7%) were female, 228 (76.5%) were white, and 57 (19.1%) were Hispanic. The most common cancer types were breast (45.3%) and hematologic (15.7%). At week 8, mean change in HADS anxiety score was -3.12 (95% CI -3.59 to -2.65) in MT and -2.97 (95% CI -3.45 to -2.50) in CBT; between-group difference was -0.15 (95% CI -0.78 to 0.49), which was within margin of 1.20 (P < 0.001 for noninferiority of MT; calculated from SD of 3.42). At week 26, mean change was -3.31 (95% CI -3.78 to -2.85) in MT and -3.00 (95% CI -3.47, -2.53) in CBT; between-group difference was -0.31 (95% CI -0.95 to 0.32), which was within margin of 1.30 (P < 0.001 for noninferiority of MT; calculated from SD of 3.65). Both groups produced anxiety reductions exceeding MCID of 1.7 and showed similar improvements in secondary outcomes. Conclusions: MT was non-inferior to CBT for short- and long-term anxiety reduction among diverse survivors of various cancer types. Both treatments produced clinically meaningful, durable anxiety reduction and were delivered remotely using standardized protocols, thereby increasing their reach and scalability. MT should be considered alongside first-line CBT to expand treatment options for anxiety during cancer survivorship. Clinical trial information: NCT05215353 .