Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT01525433
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical Cancer Screening Among Hispanic Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2012-01-31', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant attends cervical cancer screening', 'timeFrame': 'Within 7 months of the intervention'}], 'secondaryOutcomes': [{'measure': 'Patient Navigator', 'timeFrame': 'Elapsed time from diagnosis to clinic visit', 'description': 'Evaluation of the patient navigator program as a method to improve adherence and reduce time to follow-up among study participants who receive an abnormal Pap test result. Time to follow-up will be compared to a similar population of patients who were not part of the study who also receive a diagnosis of an abnormal Pap test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '22559251', 'type': 'DERIVED', 'citation': 'Duggan C, Coronado G, Martinez J, Byrd TL, Carosso E, Lopez C, Benavides M, Thompson B. Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women. BMC Cancer. 2012 May 6;12:170. doi: 10.1186/1471-2407-12-170.'}]}, 'descriptionModule': {'briefSummary': "In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:\n\n1. Control (no change);\n2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;\n3. A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.\n\nThe investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 21 - 64 years of age\n* Hispanic or Latina\n* Resident of the Yakima Valley, WA, USA\n* No hysterectomy\n* Last PAP test (cervical screening) more than 3 years ago\n* Last seen at the local clinic less than 5 years ago\n\nExclusion Criteria:\n\n* Less than 21 or greater than 64 years of age\n* PAP test less 3 years ago\n* Prior hysterectomy'}, 'identificationModule': {'nctId': 'NCT01525433', 'briefTitle': 'Cervical Cancer Screening Among Hispanic Women', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women', 'orgStudyIdInfo': {'id': 'FHCRC IR 7290'}, 'secondaryIdInfos': [{'id': 'U54CA153502', 'link': 'https://reporter.nih.gov/quickSearch/U54CA153502', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Intensity Information (DVD)', 'description': 'A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;', 'interventionNames': ['Behavioral: DVD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Intensity Information (Promotora)', 'description': "A higher intensity information program consisting of the video plus a 'promotora' or lay-community health educator led-intervention at the participant's home to encourage cervical cancer screening.", 'interventionNames': ['Behavioral: Promotora']}], 'interventions': [{'name': 'DVD', 'type': 'BEHAVIORAL', 'description': 'Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening', 'armGroupLabels': ['Low Intensity Information (DVD)']}, {'name': 'Promotora', 'type': 'BEHAVIORAL', 'description': "Participants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening", 'armGroupLabels': ['High Intensity Information (Promotora)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Beti Thompson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}