MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors

NCT06274034 | Recruiting Early Phase 1

• 2 other identifiers: 23-006870NCI-2024-01019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline; 6 weeks

Study Arms (1)

Supportive Care (MUSE S headband, meditation)

EXPERIMENTAL

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.

Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Procedure: Meditation Therapy; Other: Survey Administration

Interventions

Meditation Therapy PROCEDURE

Participate in meditation

Also known as: Meditation

Supportive Care (MUSE S headband, meditation)

Electronic Health Record Review OTHER

Ancillary studies

Supportive Care (MUSE S headband, meditation)

Medical Device Usage and Evaluation OTHER

Wear MUSE S headband

Supportive Care (MUSE S headband, meditation)

Survey Administration OTHER

Ancillary studies

Supportive Care (MUSE S headband, meditation)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Meditation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stacy D. D'Andre, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 23, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)