Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT06361056
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials
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': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Mobile Health Application (mHealth app)- subjects', 'timeFrame': 'Up to 1 year', 'description': 'The feasibility of the mHealth app will be determined by the percentage of subjects who enrolled and completed trial requirements.'}, {'measure': 'Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff', 'timeFrame': 'Up to 1 year', 'description': 'Clinicians and staff will be interviewed to assess feasibility.'}], 'secondaryOutcomes': [{'measure': 'Overall satisfaction', 'timeFrame': 'Up to 1 year', 'description': "Overall satisfaction will be assessed by survey questions administered to study participants. The rate of participants' satisfactions will be reported."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['application', 'mHealth'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer.\n\nThe "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study.', 'detailedDescription': 'A patient advisory council (PAC) was recruited from established hospital and community networks (North Carolina Cancer Hospital\'s Patient and Family Advisory Board, and the Lineberger Community Outreach and Engagement Office\'s Community Advisory Board). The PAC informed the content of interview guides, questionnaire/survey instruments, and mHealth app design, and will be involved in the analyses of qualitative and quantitative data, and dissemination of study results.\n\nAfter analysis of the in-depth interviews, the Connected Health for Applications and Interventions (CHAI) core staff developed a progressive web application "mHealth app". mHealth app was tested in a pilot study included 20 African American (AA) patients diagnosed with breast cancer were interviewed to answer questions that will better inform the clinical trial education and communication needs of Black women with breast cancer.\n\nEighty African American women with newly diagnosed breast cancer who have access to a mobile device or computer will be recruited for the study intervention. Women will receive access to the "mHealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources. Participants will complete a brief questionnaire that will assess clinical trial knowledge, how often a clinical trial discussion occurred during their oncology appointment, and if a therapeutic trial was offered.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants are women with breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* English speaking\n* Able and willing to participate to complete the survey.\n* Have access to a mobile device or computer.\n* Diagnosed with breast cancer.\n* Identify as African American\n\nExclusion Criteria:\n\n* Inability to read and speak English.\n* Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.'}, 'identificationModule': {'nctId': 'NCT06361056', 'briefTitle': 'Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'A User-centered Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials - Clinical Trial mHealth Study', 'orgStudyIdInfo': {'id': 'LCCC2140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mHealth app', 'description': 'Women enrolled in the mHealth app study will receive access to the "mHealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources.', 'interventionNames': ['Behavioral: Survey', 'Behavioral: mHealth app']}], 'interventions': [{'name': 'Survey', 'type': 'BEHAVIORAL', 'otherNames': ['Questionnaire'], 'description': 'All participants will complete a brief questionnaire.', 'armGroupLabels': ['mHealth app']}, {'name': 'mHealth app', 'type': 'BEHAVIORAL', 'description': 'Eighty Black women with newly diagnosed breast cancer (inclusive of all stages) and who have access to a mobile device or computer will be recruited to the study intervention.', 'armGroupLabels': ['mHealth app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Matthews', 'role': 'CONTACT', 'email': 'lauren_matthews@med.unc.edu', 'phone': '919-843-5321'}, {'name': 'Marjory Charlot, MD, MPH, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Lauren Matthews', 'role': 'CONTACT', 'email': 'lauren_matthews@med.unc.edu', 'phone': '919-843-5321'}], 'overallOfficials': [{'name': 'Marjory Charlot, MD, MPH, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conquer Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}