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Life sciences · Interventional Study
ClinicalTrials.gov · October 26, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07549685). This is a study registration, not published results. Lead sponsor: Istituto di Studi Superiori Musicali (ISSM) Conservatorio Antonio Vivaldi di Alessandria. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 24 participants (ACTUAL). Conditions: Breast Cancer. Interventions: OTHER: Music Therapy. Primary outcome measures: State-Trait Anxiety Inventory , Every single session : 5 minutes before and 10 minutes after. Brief summary: This study aims to evaluate the feasibility and potential benefits of music therapy in patients with breast cancer undergoing adjuvant chemotherapy. Breast cancer patients often experience significant physical and psychological symptoms during treatment, including anxiety, fatigue and reduced quality of life. Music therapy is a promising non-pharmacological intervention that may help improve psychological well-being and symptom management. However, current evidence is mainly based on group-level studies and does not account for individual variability in response. This pilot study is designed as a series of combined N-of-1 trials, in which each participant alternates periods with and without music therapy, acting as her own control. A total of 24 patients will be recruited from two Italian oncology centres and randomly assigned to different intervention sequences. The intervention consists of weekly group music therapy sessions lasting approximately 60 minutes, including both active and receptive techniques, along with personalized music playlists for home use. The primary objective is to assess the feasibility of this study design, including recruitment, retention, data completeness and acceptability of the intervention. Secondary objectives include exploring the effects of music therapy on psychological and physical well-being, as well as estimating variability in individual responses. The results of this study will inform the design of future larger studies aimed at evaluating the effectiveness of music therapy using personalised trial approaches.