Health TrialsbyHealthPanel

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

ConditionBreast Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Medical Device Usage and Evaluation

    Other intervention

    Wear MUSE S headband

  • Meditation Therapy

    Procedure/Surgery

    Participate in meditation

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Supportive Care (MUSE S headband, meditation)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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