Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT06350500
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2024-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Patient Navigation Program for Addressing Disparities in Breast Cancer Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062526', 'term': 'Patient Navigation'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'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': 126}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment rate', 'timeFrame': 'Up to 2 years', 'description': "Enrollment rate Will be defined as the number of patients enrolled divided by the number of patients approached. The enrollment rate will be estimated with a 90% credible region obtained by Jeffrey's prior method."}, {'measure': 'Reasons for refusal', 'timeFrame': 'Up to 2 years', 'description': 'Reported reasons of refusal will be summarized using frequencies and relative frequencies'}, {'measure': 'Retention Rate', 'timeFrame': 'Up to 2 years', 'description': 'The number of patients that complete patient navigation divided by the number of patients enrolled'}, {'measure': 'Reasons for discontinuation', 'timeFrame': 'Up to 2 years', 'description': 'Will be summarized using frequencies and relative frequencies'}], 'secondaryOutcomes': [{'measure': 'European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)', 'timeFrame': 'Up to 2 years', 'description': 'the quality of life in breast cancer patients. Score averaged, transformed to 0-100 scale, higher score indicates better quality of life'}, {'measure': 'Social Determinates of health', 'timeFrame': 'Up to 2 years', 'description': 'An 11 question survey . A score of 11 or more when the numerical values for answers to questions 7-10 are added shows that the person might not be safe.'}, {'measure': 'Barriers to care', 'timeFrame': 'Up to 2 years', 'description': 'Patient navigators will meet with participants to discuss barriers to care. Results will be summarized'}, {'measure': 'Use of supportive services', 'timeFrame': 'Up to 2 years', 'description': 'Will be summarized using frequencies and relative frequencies'}, {'measure': 'Patient Satisfaction survey', 'timeFrame': 'up to 2 years', 'description': 'Will be summarized (by time as appropriate) using frequencies and relative frequencies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma', 'Breast Ductal Carcinoma in Situ']}, 'descriptionModule': {'briefSummary': 'This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Implement a patient navigation program in the Roswell Park Breast Clinic focused on underserved women with a first cancer diagnosis of breast cancer or ductal carcinoma in situ (DCIS) (n=126).\n\nSECONDARY OBJECTIVE:\n\nI. Systematically address barriers to care by connecting women with multiple barriers of care with a first diagnosis of breast cancer or DCIS to supportive services and culturally appropriate resources.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have a confirmed diagnosis of breast cancer or Ductal Carcinoma In Situ (DCIS)\n* Currently identify their gender as woman or female\n* Was assigned female sex at birth (AFAB)\n\n \\- Participant is experiencing ≥1 barrier to care as determined by the social needs screening tool\n* Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention\n\nExclusion Criteria:\n\n* Participants who are not suspected of or diagnosed with breast cancer or Ductal Carcinoma in Situ (DCIS)\n* Participants who have had a previous diagnosis of any cancer\n* Participants who were assigned male sex or intersex at birth\n* Unwilling or unable to follow protocol requirements'}, 'identificationModule': {'nctId': 'NCT06350500', 'briefTitle': 'A Patient Navigation Program for Addressing Disparities in Breast Cancer Care', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Addressing Disparities in Breast Cancer Care: An Approach to Health Equity', 'orgStudyIdInfo': {'id': 'I-3858823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health Services Research (Patient Navigation)', 'description': 'Patients receive patient navigation services from a patient navigator as needed to improve knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance skills related to management of cancer treatment', 'interventionNames': ['Behavioral: Patient Navigation', 'Other: Questionnaire']}], 'interventions': [{'name': 'Patient Navigation', 'type': 'BEHAVIORAL', 'description': 'Receive patient navigation', 'armGroupLabels': ['Health Services Research (Patient Navigation)']}, {'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Health Services Research (Patient Navigation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'ASK RPCI', 'role': 'CONTACT', 'email': 'askrpci@roswellpark.org', 'phone': '877-275-7724'}], 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Kathryn Glaser', 'role': 'CONTACT', 'email': 'Kathryn.Glaser@roswellpark.org', 'phone': '716-845-7637'}], 'overallOfficials': [{'name': 'Kathryn Glaser', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}