Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT01351220
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2011-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community Dissemination of an Evidence-based Colorectal Cancer (CRC) Screening Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2011-05-06', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in receipt of CRC screening at 6 months and 24 months', 'timeFrame': 'baseline, 6-month and 24-month post intervention', 'description': 'Subjects will receive any one of the 3 recommended CRC screening tests namely, Fecal Occult Blood Test, Flexible sigmoidoscopy or Colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in intention to obtain screening at 6 months and 24 months', 'timeFrame': 'baseline, 6-months and 24-months after exposure to the intervention'}, {'measure': 'Change from Baseline in CRC screening knowledge at 6 months and 24 months', 'timeFrame': 'baseline, 6 months and 24 months after exposure to the educational program'}, {'measure': 'Change from Baseline in frequency of patient provider communication at 6 months and 24 months', 'timeFrame': 'baseline, 6 and 24 months after exposure to the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CRC screening', 'Prevention and early detection of CRC', 'Filipino', 'Dissemination'], 'conditions': ['Colon Cancer', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '20864724', 'type': 'BACKGROUND', 'citation': 'Maxwell AE, Bastani R, Danao LL, Antonio C, Garcia GM, Crespi CM. Results of a community-based randomized trial to increase colorectal cancer screening among Filipino Americans. Am J Public Health. 2010 Nov;100(11):2228-34. doi: 10.2105/AJPH.2009.176230. Epub 2010 Sep 23.'}, {'pmid': '28948137', 'type': 'DERIVED', 'citation': 'Maxwell AE, Crespi CM, Arce AA, Bastani R. Exploring the effects of longstanding academic-community partnerships on study outcomes: A case study. Prev Med Rep. 2017 Sep 12;8:101-107. doi: 10.1016/j.pmedr.2017.09.003. eCollection 2017 Dec.'}, {'pmid': '27282431', 'type': 'DERIVED', 'citation': 'Maxwell AE, Danao LL, Cayetano RT, Crespi CM, Bastani R. Implementation of an evidence-based intervention to promote colorectal cancer screening in community organizations: a cluster randomized trial. Transl Behav Med. 2016 Jun;6(2):295-305. doi: 10.1007/s13142-015-0349-5.'}]}, 'descriptionModule': {'briefSummary': 'Filipino Americans have lower rates of colorectal cancer (CRC) screening, later stage of diagnosis and poorer survival relative to other racial/ethnic groups. To address this disparity, the investigators developed a multi-component intervention to increase CRC screening and have determined its efficacy in a randomized trial (Maxwell,et. al., 2010). This study aims to determine how an intervention to increase CRC screening can best be integrated within the cultural norms and existing structures of churches and community based organizations (CBOs) with predominantly Filipino American membership to ensure broad dissemination to those in need of screening.\n\nThe investigators will provide our partner CBOs with resources and technical assistance, including training of community volunteers as health advisors, to enable them to promote CRC screening to their constituents. Using a scientifically rigorous research design, the investigators will compare two dissemination strategies: Basic dissemination which consists of a single kick-off event during which community health advisors will receive print materials and FOBT kits for distribution and training on how to conduct educational small-group sessions; and Organizational dissemination aimed at integrating CRC screening dissemination into organizational practices and processes that can be sustained after the end of the study. The study will be implemented in 20 CBOs and will train 100 community health advisors (CHAs). The impact of the two dissemination strategies will be comprehensively assessed by collecting data at the CBO level, from the CHAs and from 1000 Filipino American participants. The investigators will compare the proportion of Filipino American participants who obtain CRC screening by dissemination strategy, but the investigators will also assess how many are reached, if the intervention is implemented as planned, how CBOs support the screening efforts at their regular activities, and if CBOs and CHAs maintain their efforts over the 4 years of the study.\n\nThe investigators hypothesize that CBOs can implement evidence-based strategies to promote CRC screening and CHAs in the organizational dissemination arm will reach more participants and more screened participants than CHAs in the basic dissemination arm; and organizations in the organizational dissemination arm will adopt more CRC screening activities and maintain these better than organizations in the basic dissemination arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Filipino American\n* 50 to 75 years of age\n* Must not have been diagnosed with CRC\n* Must not be adherent to USPSTF CRC screening guidelines\n\nExclusion Criteria:\n\n* Not Filipino American\n* Younger than 50 or older than 75 years of age\n* Have been diagnosed with CRC\n* Adherent to USPSTF CRC screening guidelines'}, 'identificationModule': {'nctId': 'NCT01351220', 'briefTitle': 'Community Dissemination of an Evidence-based Colorectal Cancer (CRC) Screening Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Community Dissemination of an Evidence-based CRC Screening Intervention', 'orgStudyIdInfo': {'id': 'RSGT CPPB-119384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Basic dissemination', 'interventionNames': ['Behavioral: Educational program and FOBT kits']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Organizational dissemination', 'interventionNames': ['Behavioral: Educational program and FOBT kits, and technical assistance']}], 'interventions': [{'name': 'Educational program and FOBT kits', 'type': 'BEHAVIORAL', 'description': 'Subjects will participate in a CRC small group educational program and receive FOBT kits from community health advisors who have received a one-time training session.', 'armGroupLabels': ['Basic dissemination']}, {'name': 'Educational program and FOBT kits, and technical assistance', 'type': 'BEHAVIORAL', 'description': "In addition to subjects' receipt of a CRC small group educational program and FOBT kits, leadership training and technical support will be provided to the community health advisors and selected leaders and members of the organization.", 'armGroupLabels': ['Organizational dissemination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-6900', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Division of Cancer and Prevention Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Annette E Maxwell, Dr.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Leda L Danao, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}