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Behavioural Intervention

Supportive Care (MUSE S headband, meditation) for Breast Cancer

Phase < 1
Recruiting
Led By Stacy D. D'Andre, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-80
Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial is testing a meditation headband system called MUSE-S to see if it can help breast cancer survivors with anxiety and insomnia. These issues are common among breast cancer survivors and can affect their well

Who is the study for?
This trial is for breast cancer survivors who are experiencing anxiety and insomnia. Participants should be interested in trying a meditation headband system called MUSE-S to help manage their stress.Check my eligibility
What is being tested?
The study is testing the MUSE-S Headband System, which guides users through meditation using EEG technology. It aims to see if this device can improve well-being by reducing anxiety and insomnia among breast cancer survivors.See study design
What are the potential side effects?
Since the intervention involves non-invasive meditation therapy with a headband, there are minimal expected side effects. However, discomfort or skin irritation from wearing the device may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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My breast cancer was first diagnosed within the last 10 years.
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I am experiencing anxiety and insomnia, both worse than 3 out of 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)
Frequency of use of meditation
Impact of interactive meditation and sleep support through the Muse-S™ system

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (MUSE S headband, meditation)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meditation Therapy
2018
N/A
~50

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,448 Total Patients Enrolled
83 Trials studying Breast Cancer
13,810 Patients Enrolled for Breast Cancer
Stacy D. D'Andre, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for patient enrollment in this clinical trial?

"Affirmative. The details on clinicaltrials.gov indicate that this investigation is actively seeking participants. This trial was first listed on January 8th, 2024, and the most recent update occurred on February 22nd, 2024. In total, they aim to recruit 40 patients from a single site."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, details available on clinicaltrials.gov affirm the ongoing recruitment status of this investigation. The trial was initially published on January 8th, 2024 and recently revised on February 22nd, 2024. Specifically, the study aims to enroll a total of 40 participants from one designated site."

Answered by AI

Are individuals older than 18 years of age eligible to participate in this medical trial?

"Eligible candidates for this research are individuals between 18 and 80 years old. It is noteworthy that there are a total of 61 trials catering to those under 18 and 2281 studies targeting participants over the age of 65."

Answered by AI
~27 spots leftby Jan 2025