Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-17 @ 6:16 PM
Study NCT ID:
NCT01910350
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical 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'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 516}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First time AND appropriately timed, clinical breast exam, mammogram, pap test', 'timeFrame': 'Baseline through 36 months.', 'description': 'Participants will complete measures every 6 months (baseline, 12 mo., 18 mo., 24 mo., 30 mo. \\& 36 mo.)to measure increases in screening rates for experimental vs. control group.'}], 'secondaryOutcomes': [{'measure': 'Increased Breast and Cervical Cancer Literacy rates.', 'timeFrame': 'Baseline-36 months.', 'description': 'Do participants have a higher breast and cervical cancer literacy rates post intervention and over 36 months than control group as well as better retention?'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast & cervical cancer prevention & screening'], 'conditions': ['Breast Cancer', 'Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '23274402', 'type': 'BACKGROUND', 'citation': 'Williams KP, Roman L, Meghea CI, Penner L, Hammad A, Gardiner J. Kin KeeperSM: design and baseline characteristics of a community-based randomized controlled trial promoting cancer screening in Black, Latina, and Arab women. Contemp Clin Trials. 2013 Mar;34(2):312-9. doi: 10.1016/j.cct.2012.12.005. Epub 2012 Dec 28.'}]}, 'descriptionModule': {'briefSummary': '1\\) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To measure functional cancer literacy over time at the individual and familial level and 4) Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and control-comparison groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants:self-identified as Black Latina and Arab women ho can recruit at least two bloodline female family members (mother daughter sister, etc.; can accommodate two in-home visits by a community health worker; and 21-70 years of age.\n\nExclusion Criteria:\n\n* are not self-identified as Black, Latina, or Arab; do not have direct bloodline relatives; and are younger than 21 or older than 70 years of age.'}, 'identificationModule': {'nctId': 'NCT01910350', 'acronym': 'KinKeeper', 'briefTitle': 'Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening', 'orgStudyIdInfo': {'id': '10-256'}, 'secondaryIdInfos': [{'id': '1R01NR011323', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR011323', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cancer prevention intervention', 'description': 'Cancer prevention intervention: Experimental group receives intensive 2 hour education in each breast and cervical cancer risks and prevention intervention, and face to face reading of post intervention surveys by an community health worker.', 'interventionNames': ['Behavioral: Kin KeeperSM Cancer Prevention Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group receives standard care', 'description': 'The control group receives reading materials and brochures on breast and cervical cancer such as one would receive in a doctors office and post condition surveys. All materials are read by the participant without the interaction or assistance of the community health worker.', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Kin KeeperSM Cancer Prevention Intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Cancer prevention intervention']}, {'name': 'Standard of care', 'type': 'OTHER', 'armGroupLabels': ['Control group receives standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Karen Williams', 'investigatorAffiliation': 'Michigan State University'}}}}