Clinical trial NCT06274034: MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
Official title: Pilot Study of a Wearable EEG Headband As a Meditation Device for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Frequency of use of meditation
timeFrame: Baseline; 6 weeks
measure: Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)
timeFrame: 6 weeks
measure: Impact of interactive meditation and sleep support through the Muse-S™ system
timeFrame: Baseline; 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Stacy D. D'Andre, MD
role: PRINCIPAL_INVESTIGATOR
References: