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Trial Title:
MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
NCT ID:
NCT06274034
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Supportive Care (MUSE S headband, meditation)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear MUSE S headband
Arm group label:
Supportive Care (MUSE S headband, meditation)
Intervention type:
Procedure
Intervention name:
Meditation Therapy
Description:
Participate in meditation
Arm group label:
Supportive Care (MUSE S headband, meditation)
Other name:
Meditation
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (MUSE S headband, meditation)
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.
Detailed description:
PRIMARY OBJECTIVES:
I. To evaluate the frequency of use of meditation (a stress management technique) among
breast cancer survivors.
II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with
smartphone or tablet application (app) to guide breast cancer survivors' interactive
meditation and sleep support.
III. To measure the impact of interactive meditation and sleep support through MUSE S
among breast cancer survivors during or after chemotherapy on improving symptoms of
anxiety and insomnia.
OUTLINE:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Stacy D. D'Andre, M.D.
Email:
Principal Investigator
Start date:
January 8, 2024
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06274034
https://www.mayo.edu/research/clinical-trials
