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.
PRIMARY OBJECTIVES: I. To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors. II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support. III. To measure the impact of interactive meditation and sleep support through MUSE S among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia. OUTLINE: Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
Ancillary studies
Wear MUSE S headband
Participate in meditation
Ancillary studies
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Frequency of use of meditation
Assessed by the number of times participant uses the Muse™ S Headband system and app. Data will be downloaded from the Muse Dashboard to the study team.
Time frame: Baseline; 6 weeks
Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)
Assessed by reviewing usage data and by post-study satisfaction questionnaire adapted from the Was it Worth it Questionnaire (WIWI) asking the patient if the entire research experience, including the intervention, was worth it for them. The WIWI questionnaire includes 3 items: (item 1) Was it worthwhile for you to receive the cancer treatment given in this study? (item 2) If you had to do it over again, would you choose to have this cancer treatment? and (item 3) Would you recommend this cancer treatment to others? Questions are answered with yes, uncertain, or no.
Time frame: 6 weeks
Impact of interactive meditation and sleep support through the Muse-S™ system
Assessed by a 3-section questionnaire (sleep, quality of life, and anxiety) with a variety of questions answered by multiple choice (e.g., very well, somewhat well, not very well, not well at all) or answered on a scale of 1-10 where 1=as bad as it can band and 10=as good as it can be.
Time frame: Baseline; 6 weeks
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