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Life sciences · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · September 15, 2026
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Phase EARLY_PHASE1 Trial.
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Registry record from ClinicalTrials.gov (NCT06274034). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: TERMINATED. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 14 participants (ACTUAL). Conditions: Breast Carcinoma. Interventions: OTHER: Electronic Health Record Review; OTHER: Medical Device Usage and Evaluation; PROCEDURE: Meditation Therapy; OTHER: Survey Administration. Primary outcome measures: Frequency of use of meditation , Baseline; 6 weeks; Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband) , 6 weeks; Impact of interactive meditation and sleep support through the Muse-S™ system , Baseline; 6 weeks. Brief summary: This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors.