Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-30 @ 8:49 AM
Study NCT ID:
NCT06274034
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of use of meditation', 'timeFrame': 'Baseline; 6 weeks', 'description': '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.'}, {'measure': 'Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Impact of interactive meditation and sleep support through the Muse-S™ system', 'timeFrame': 'Baseline; 6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors.\n\nII. 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.\n\nIII. 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.\n\nOUTLINE:\n\nPatients 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18-80\n* Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years\n* Patients report experiencing anxiety and insomnia both rated \\> 3 on a 0-10 scale (with 0 indicating none) at the time of enrollment\n* 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\n* Has smart phone or tablet\n* Patient willing to use Google-based anonymous email account to sign up for MUSE\n* Be willing to provide informed consent and complete all aspects of the study\n* 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\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding individuals\n* 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\n* Currently taking medication for insomnia\n* An exclusionary unstable medical or mental health condition as determined by the patient's oncologist"}, 'identificationModule': {'nctId': 'NCT06274034', 'briefTitle': 'MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '23-006870'}, 'secondaryIdInfos': [{'id': 'NCI-2024-01019', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '23-006870', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive Care (MUSE S headband, meditation)', 'description': '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.', 'interventionNames': ['Other: Electronic Health Record Review', 'Other: Medical Device Usage and Evaluation', 'Procedure: Meditation Therapy', 'Other: Survey Administration']}], 'interventions': [{'name': 'Electronic Health Record Review', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (MUSE S headband, meditation)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Wear MUSE S headband', 'armGroupLabels': ['Supportive Care (MUSE S headband, meditation)']}, {'name': 'Meditation Therapy', 'type': 'PROCEDURE', 'otherNames': ['Meditation'], 'description': 'Participate in meditation', 'armGroupLabels': ['Supportive Care (MUSE S headband, meditation)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive Care (MUSE S headband, meditation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': "Stacy D. D'Andre, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': "Stacy D. D'Andre, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}