Recruiting
Early Phase 1

MUSE-S

Sponsor:

Mayo Clinic

Code:

NCT06274034

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Medical Device Usage and Evaluation

Meditation Therapy

Survey Administration

Study Details

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.

Conditions

Breast Carcinoma

Study ID

NCT06274034

Start date

Jan 8, 2024

Status verified date

May, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care (MUSE S headband, meditation)

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

Electronic Health Record Review

Ancillary studies

Medical Device Usage and Evaluation

Wear MUSE S headband

Meditation Therapy

Participate in meditation

Survey Administration

Ancillary studies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Stacy D. D'Andre, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-02.