Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:04 PM
Study NCT ID:
NCT04070534
Status:
SUSPENDED
Last Update Posted:
2025-08-15
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PALS for Pap Smear Follow up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Investigator is actively pursuing additional funding to continue the work. Once funding is secured, the study will recruit additional patients.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reusable knowledge objects (RKOs)', 'timeFrame': 'Month 1-2', 'description': 'Knowledge of cervical cancer screening and treatment, and perceived barriers, as measured in qualitative interviews'}, {'measure': 'Knowledge change', 'timeFrame': 'Month 3-4', 'description': 'Quantitative change in knowledge post-intervention, as measured by attendance rates at follow-up visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': 'In this study, the researchers will utilize information gained from patient interviews about their knowledge of the cervical cancer screening and treatment process, and perceived barriers surrounding appropriate follow up, to create content for the intervention.', 'detailedDescription': "The overall goal of this research is to develop and test an intervention designed to improve knowledge and follow up among underserved women with abnormal pap smears. The researchers will use a unique web-based platform, the Patient Activated Learning System (PALS), which provides engaging and informative video and text designed to improve patient knowledge specifically among underserved populations. Twenty diverse patients with abnormal pap smears will be recruited from the Women's Health colposcopy clinic for initial qualitative interviews. Forty patients from the same population will then be engaged in a pre-post pilot to examine feasibility, acceptability, and impact of modules on improving knowledge."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All Women 21-65 years with diagnosis of abnormal pap smear presenting to Women's Health Colposcopy Clinic at WCMC\n* Access to a smartphone\n* English or Spanish Speaking\n\nExclusion Criteria:\n\n* Pregnant women\n* Non-English or Spanish speakers"}, 'identificationModule': {'nctId': 'NCT04070534', 'acronym': 'PALS', 'briefTitle': 'PALS for Pap Smear Follow up', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Utilization Of A Web-Based Platform (Patient Activated Learning System- PALS) To Improve Knowledge And Follow-Up Among Women With Abnormal Cervical Cancer Screening (PALS)', 'orgStudyIdInfo': {'id': '19-05020040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PALS intervention', 'description': 'This arm will influence the development of a patient-directed education module using the Patient Activated Learning System (PALS)', 'interventionNames': ['Other: PALS']}], 'interventions': [{'name': 'PALS', 'type': 'OTHER', 'description': 'patient activated learning system', 'armGroupLabels': ['PALS intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Prebyterian Hospital Weill Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Eloise Chapman-Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}