Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06271356
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breast Cancer - Navigate - Prospective Cohort
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demand of BC-Navi: Recruitment Rate', 'timeFrame': '12 weeks', 'description': 'We assess the demand for the BC-Navi application through study recruitment. Based on previous psychosocial and behavioral studies in oncology, a 75% recruitment rate is considered adequate.'}, {'measure': 'Demand of BC-Navi: Retention Rate', 'timeFrame': '12 weeks', 'description': 'Another way we assess demand of the BC-Navi application is through participant retention. Based on previous psychosocial and behavioral studies in oncology, a 75% retention rate is considered adequate .'}, {'measure': 'Acceptability of BC-Navi', 'timeFrame': '12 weeks', 'description': 'To assess acceptability, all participants are asked to complete an exit interview on BC-Navi. This interview assesses the usefulness, satisfaction, learnability, and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above-average scores on the questionnaire are considered acceptable.'}, {'measure': 'Preliminary Efficacy: Chemotherapy Initiation', 'timeFrame': '12 weeks', 'description': 'Preliminary efficacy will be measured by time to chemotherapy initiation, which will be operationalized as chemotherapy treatment initiation within 90 days of completion of surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eHealth'], 'conditions': ['Breast Cancer', 'Quality of Life', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': "The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.\n\nTCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.\n\nTherefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Diagnosed with non-metastatic breast cancer (stages I-III)\n* An order placed for a post-operative chemotherapy cycle by a NM clinician\n* Not have initiated a recommended post-operative chemotherapy cycle at the time of study enrollment\n* Completed surgery for breast cancer\n* First-time diagnosis of breast cancer\n* Established care at Northwestern Medicine\n* English-speaking as the navigation website is not yet available in other languages\n* Access to internet on a smart phone or computer/tablet\n* Any ethnic background\n* We will only consider patients that sign an informed consent form\n\nExclusion Criteria:\n\n* Men will be excluded because the navigation website only contains content and resources for women. Men also make up less than 1% of all breast cancer diagnoses and the Breast Cancer-Navigate app/website content was developed for female breast cancer patients.\n* Diagnosis of additional, life-threatening condition (e.g., end-stage renal disease, heart failure) which can interfere with timely planned adjuvant chemotherapy treatment for cancer.'}, 'identificationModule': {'nctId': 'NCT06271356', 'briefTitle': 'Breast Cancer - Navigate - Prospective Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Effect of a Navigation Intervention on Care Equity for Women of Color Diagnosed With Breast Cancer: A Feasibility Study', 'orgStudyIdInfo': {'id': 'STU00220278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BC-Navi', 'description': "Apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant chemotherapy treatment among diverse breast cancer patients.", 'interventionNames': ['Behavioral: BC-Navigate']}], 'interventions': [{'name': 'BC-Navigate', 'type': 'BEHAVIORAL', 'description': 'BC-Navigate is a website/application to help guide women through care delivery during breast cancer treatment.', 'armGroupLabels': ['BC-Navi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Buitrago', 'role': 'CONTACT', 'email': 'diana.buitrago@northwestern.edu', 'phone': '312-503-2866'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Betina Yanez', 'role': 'CONTACT', 'email': 'betina.yanez@northwestern.edu', 'phone': '312-503-5341'}, {'name': 'Alma Diaz', 'role': 'CONTACT', 'email': 'alma.diaz@northwestern.edu', 'phone': '224-789-9601'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Chrysalis Initiative', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Betina Yanez', 'investigatorAffiliation': 'Northwestern University'}}}}