Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00836303
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2009-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-02', 'studyFirstSubmitDate': '2009-02-02', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of Colorectal cancer screening', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'physician recommendation for colorectal cancer screening'}, {'measure': 'Patient adherence to physician recommended colorectal cancer screening test', 'timeFrame': '3 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hispanichealth.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study will assess the effectiveness of a culturally-responsive intervention to increase colorectal cancer (CRC) screening among Latino immigrants in a primary care clinic setting of a large municipal Hospital in New York City. propose a randomized, control trial to determine if a video-based intervention, that educates and activates the patient and the provider via the patient, will increase rates of CRC screening referrals compared to a control group.\n\nColorectal cancer remains one of the most prevalent cancers among the general population, as well as in the Latino population, in the United States. There are serious disparities in CRC screening rates between different races and socio-demographic populations (American Cancer Society: Colorectal Cancer Facts and Figures - Special Edition 2005). Latino immigrants are one of the populations most affected by the lack of screening, reducing their relative benefit from preventive CRC services. This study will use a modified version of an intervention developed and studied by Pignone (11), with changes made to be tailored specifically to the Latino immigrant population. The outcomes measured will include referral for CRC screening and adherence with providers' referrals. In addition, the investigators will measure screening rates for other cancer screening tests to assess if the CRC intervention displaces or facilitates other cancer screening. A sample of Latino immigrants seeking care at the primary care clinic of Bellevue Hospital will be accrued through a process of consecutive sampling until reaching the proposed sample size of 101 patients in each group (alpha 0.05 and power of 80%). To analyze the effectiveness of the intervention the investigators will use the z-test and will report the difference in proportion between the intervention and the control group with a 95% CI, adjusting for intra-class correlations and covariates. A repeated measurement analysis with logistic regression will be used to examine the effects of covariates."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Latino immigrants\n* Men and women\n* 50 years and older\n* Having had at least 2 previous visits to the primary care clinic in the past 2 years\n\nExclusion Criteria:\n\n* Personal or family history of colorectal cancer.\n* Had fecal occult blood testing (FOBT) in the past year, or flexible sigmoidoscopy or barium enema in the past 5 years, or colonoscopy in the past 10 years.\n* Lower gastrointestinal symptoms, including bleeding, pain, diarrhea and/or constipation.\n* Too ill to participate\n* Any cancer diagnosis other than non-melanoma skin cancer.'}, 'identificationModule': {'nctId': 'NCT00836303', 'briefTitle': 'Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Randomized Controlled Trial of a Multilevel Intervention to Increase Colorectal Cancer Screening Among Latino Immigrants in a Primary Care Facility', 'orgStudyIdInfo': {'id': 'T01CD000146', 'link': 'https://reporter.nih.gov/quickSearch/T01CD000146', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients of physicians randomly assigned to the control group received usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'This group will receive the behavioral intervention.', 'interventionNames': ['Behavioral: Colorecatal Cancer Screening Activation']}], 'interventions': [{'name': 'Colorecatal Cancer Screening Activation', 'type': 'BEHAVIORAL', 'description': "Research assistants showed intervention patients a colorectal cancer educational video in Spanish on a portable personal digital video display device while the patients were waiting for their visit. The 11-minute video was developed by the National Alliance for Hispanic Health and was accompanied by a brochure with key information from the video {http://www.hispanichealth.org/publication/}. Intervention patients were also given a one-page reminder to hand to their physicians notifying them 1) of their patients' eligibility for colorectal cancer screening, and 2) of their patients' receipt of CRC educational material.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Francesca M Gany, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Francesca M. Gany/Associate Professor', 'oldOrganization': 'New York University School of Medicine'}}}}