Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT00385866
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2006-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}, {'id': 'D062526', 'term': 'Patient Navigation'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'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'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'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': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2006-10-10', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce the disparities observed in utilization of cancer screening services', 'timeFrame': '2-4 years'}], 'secondaryOutcomes': [{'measure': 'Improve the time to diagnosis and treatment services (resulting in reduced cost of cancer care', 'timeFrame': '4 years'}, {'measure': 'Improve patient satisfaction and informed decision making.', 'timeFrame': '4 years'}]}, 'conditionsModule': {'keywords': ['Patient Navigator', 'Community health', 'Communication'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'To reduce Cancer health care disparities that exists among minority Medicare beneficiaries and to demonstrate cost effectiveness of patient navigation in reducing the burden of cancer.', 'detailedDescription': 'The Latino population is the fastest growing minority population in the United States . Cancer ranks as the second leading cause of death among Latinos in the United States (24%), second only to heart disease . This project will evaluate whether an innovative facilitation program (targeting cancers of the prostate, colon/rectum, breast, and cervix) will improve cancer outcomes among Latino Medicare beneficiaries in the city of Newark, New Jersey.\n\nThe overall aim of this project is to institute an innovative cancer care facilitation program for elderly Latinos in the city of Newark, NJ. The goal is to reduce the disparities observed in screening, time to diagnosis and treatment services, by utilizing a multidisciplinary team approach to health care, incorporating systems thinking methodology. Using the Multilevel Approach to Community Health (MATCH) planning model , the program will incorporate community outreach, education, and access to screening, and patient assistance in all aspects of the health care continuum. It will also include cultural and linguistic competency training for all those involved in the facilitation process. To accomplish this goal, we propose four objectives:\n\n1. To establish a multidisciplinary team that will utilize a systems thinking approach to design and structure the delivery of cancer screening, diagnosis and treatment facilitation services.\n2. To build a collaborative consortium between program partners to improve screening outcomes, that will encourage the utilization of services in the community.\n3. To improve the delivery of cancer prevention and treatment facilitation by providing cultural and linguistic competency training to the multidisciplinary team, providers, and the community.\n4. To demonstrate the effectiveness of the intervention in reducing the burden of cancer, by increasing screening rates, improving time to diagnosis and delivery of treatment services, patient satisfaction, and appropriate use of Medicare services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCancer-Negative Group\n\n1. Be of Hispanic/Latino Origin\n2. Fluent in English and/or Spanish\n3. Recipient of, Medicare Part A \\& B, or combined Medicare/Medicaid\n4. Not having a previous diagnosis of cancer\n5. Be capable of giving written informed consent prior to any study related procedures.\n6. Be available and willing to complete all study assessments as specified.\n\nCancer-Positive Group\n\n1. Be of Hispanic/Latino Origin\n2. Fluent in English and/or Spanish\n3. Recipient of, Medicare Part A \\& B, or combined Medicare/Medicaid\n4. Having a previous diagnosis of cancer of the breast, cervix, colon and/or rectum, prostate, or lung.\n5. Be capable of giving written informed consent prior to any study related procedures.\n6. Be available and willing to complete all study assessments as specified.\n\nExclusion Criteria:\n\n1. Member of the Medicare Advantage Plan, any Medicare managed care plan (Those who join the Medicare Advantage plan or a managed care plan during the course of the study will become ineligible to continue.)\n2. Medicaid only beneficiaries\n3. Institutionalized\n4. Unable to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT00385866', 'briefTitle': 'Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Addressing Disparities in Cancer Care for Latino Medicare Beneficiaries', 'orgStudyIdInfo': {'id': '0120060236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison Group', 'description': 'The control or lesser intervention group, will receive cancer screening information on a quarterly basis, with no facilitation of services.', 'interventionNames': ['Behavioral: cancer screening and health education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'The intervention group are those participants who were randomly assigned to receive facilitation of services in the form of patient navigation for the duration of the study.', 'interventionNames': ['Behavioral: cancer screening and health education', 'Behavioral: facilitation of Services to improve cancer screening']}], 'interventions': [{'name': 'cancer screening and health education', 'type': 'BEHAVIORAL', 'otherNames': ['patient navigation', 'cancer screening and education'], 'description': 'The control group will receive cancer screening and health education materials on a quarterly basis but will not have access to patient navigation services.', 'armGroupLabels': ['Comparison Group', 'Intervention group']}, {'name': 'facilitation of Services to improve cancer screening', 'type': 'BEHAVIORAL', 'otherNames': ['patient navigation', 'faciliation of services', 'screening'], 'description': 'The intervention group will receive cancer education and faciliation of services in the form of patient navigation', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07107', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Ana Natale-Pereira, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Medicare and Medicaid Services', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}