Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT05032404
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2021-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blue Note Therapeutics Product BNT 103 Usability and User Engagement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients', 'timeFrame': 'Baseline up to Week 7', 'description': 'Higher scores indicate higher ease of use / easier to use applications'}], 'secondaryOutcomes': [{'measure': 'Measure of Current Status - Anxiety (MOCS-A)', 'timeFrame': 'Baseline up to Week 7', 'description': "The MOCS-A is a 13-item self-report measure developed to assess participants' current self-perceived status on: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed, higher scores indicate greater self-perceived proficiency with these skills."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '18835434', 'type': 'BACKGROUND', 'citation': 'Antoni MH, Lechner S, Diaz A, Vargas S, Holley H, Phillips K, McGregor B, Carver CS, Blomberg B. Cognitive behavioral stress management effects on psychosocial and physiological adaptation in women undergoing treatment for breast cancer. Brain Behav Immun. 2009 Jul;23(5):580-91. doi: 10.1016/j.bbi.2008.09.005. Epub 2008 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'This test aims to explore product development-focused usability and user engagement.', 'detailedDescription': 'Sponsor is testing an innovative peer-to-peer communication tool during this trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'genderBased': True, 'genderDescription': 'Diagnosed with breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient can read, write, and speak in English\n* Patient is between the ages of 35-55\n* Diagnosed with Stage I-III breast cancer\n* In active treatment or within 3 months of ending active treatment and under the care of a clinician at time of study\n* Apple mobile phone or tablet user\n* Willing to participate in study protocol\n\nExclusion Criteria:\n\n* Any participant not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05032404', 'briefTitle': 'Blue Note Therapeutics Product BNT 103 Usability and User Engagement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Blue Note Therapeutics'}, 'officialTitle': 'BNT 103 Usability and User Engagement', 'orgStudyIdInfo': {'id': 'PROT002 - Test Plan 01 Rev A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BNT103', 'description': 'All participants receive BNT103. BNT103 provides 10 sessions over approximately 10 weeks.', 'interventionNames': ['Device: BNT103']}], 'interventions': [{'name': 'BNT103', 'type': 'DEVICE', 'description': 'BNT-103™ is a prescription digital therapeutic specifically designed to treat the symptoms of anxiety and depression related to cancer. There are 10 sessions provided over approximately 10 weeks.', 'armGroupLabels': ['BNT103']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93065', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Blue Note Therapeutics', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Dianne Shumay, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blue Note Therapeutics, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Blue Note Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Healthcare Innovation Technology Lab', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}