MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electronic Health Record Review, Medical Device Usage and Evaluation, Meditation Therapy, Survey Administration.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors
Overview
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.
Detailed description
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.
Interventions
- Other Electronic Health Record Review
Ancillary studies - Other Medical Device Usage and Evaluation
Wear MUSE S headband - Procedure Meditation Therapy
Participate in meditation - Other Survey Administration
Ancillary studies
Primary outcome measures
- Frequency of use of meditation [Time frame: Baseline; 6 weeks]
- Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband) [Time frame: 6 weeks]
- Impact of interactive meditation and sleep support through the Muse-S™ system [Time frame: Baseline; 6 weeks]
Eligibility criteria
Inclusion criteria
- Age between 18-80
- Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years
- Patients report experiencing anxiety and insomnia both rated > 3 on a 0-10 scale (with 0 indicating none) at the time of enrollment
- Patients on anti-anxiety/anti-depressant medication must be on stable dose for 1 month prior to study enrollment and must stay on that same dose throughout the trial
- Has smart phone or tablet
- Patient willing to use Google-based anonymous email account to sign up for MUSE
- Be willing to provide informed consent and complete all aspects of the study
- Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S (trademark) system, as determined by the clinical investigators
Exclusion criteria
- Pregnant or breastfeeding individuals
- Individuals who have used a regular mindfulness practice or received integrative medicine therapy, including acupuncture/acupressure, mindfulness or stress-reduction programs, massage, and/or energy therapies within the past 60 days
- Currently taking medication for insomnia
- An exclusionary unstable medical or mental health condition as determined by the patient's oncologist
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06274034 · 23-006870