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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Electronic Health Record Review
  • Medical Device Usage and Evaluation
  • Meditation Therapy
  • Survey Administration

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1
Mayo Clinic in Rochester55905, RochesterMinnesota, United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor