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New treatment option for Breast Carcinoma
Official title MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
ClinicalTrials.gov ID: NCT06274034
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 8 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- 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...
- Has smart phone or tablet
You likely can't join if
- Pregnant or breastfeeding individuals
- Individuals who have used a regular mindfulness practice or received integrative medicine therapy, including acupuncture/acupressure, mindfulness or...
- Currently taking medication for insomnia
- An exclusionary unstable medical or mental health condition as determined by the patient's oncologist
See the full eligibility 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
- 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...
- Currently taking medication for insomnia
- An exclusionary unstable medical or mental health condition as determined by the patient's oncologist
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.