Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-24 @ 3:23 AM
Study NCT ID:
NCT05762757
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-centered Educational Material to Improve Colposcopy Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-07', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in participant knowledge of colposcopy', 'timeFrame': 'Prior to viewing educational material and after viewing educational material (Day 1)', 'description': '-9 question questionnaire that will assess patient knowledge of colposcopy'}], 'secondaryOutcomes': [{'measure': 'Acceptability of educational material as measured by the Acceptability of Intervention Measure', 'timeFrame': 'Day 1', 'description': 'This is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.'}, {'measure': 'Appropriateness of educational material as measured by the Intervention Appropriateness Measure', 'timeFrame': 'Day 1', 'description': 'This is a 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.'}, {'measure': 'Feasibility of educational material as measured by the Feasibility of Intervention Measure', 'timeFrame': 'Day 1'}, {'measure': 'Number of participants who stated that the educational material will influence their intention to adhere to colposcopy', 'timeFrame': 'Day 1', 'description': 'This is a 4-item measure of perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer screening', 'colposcopy', 'patient education'], 'conditions': ['Cervical Cancer Screening']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': "The long-term goal is to develop, test, and disseminate a social needs navigator intervention that improves colposcopy adherence. Based on stakeholder feedback, this study addresses the need to include patient-centered educational material to the navigator program in order to improve patients' health literacy regarding cervical cancer prevention.", 'detailedDescription': 'The investigators will evaluate the effectiveness of the colposcopy educational material. The investigators aim to recruit 25 newly referred colposcopy patients before their appointment, ask them to take a 5-minute test about their knowledge of colposcopy, have them view an online demo of the educational resources, and then retake the test.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 years or older\n* Abnormal cervical screen confirmed by cytology or pathology\n* Referred to Washington University School of Medicine (WUSM) colposcopy clinic\n\nExclusion Criteria:\n\n* History of cervical cancer\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT05762757', 'briefTitle': 'Patient-centered Educational Material to Improve Colposcopy Adherence', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Patient-centered Educational Material to Improve Colposcopy Adherence', 'orgStudyIdInfo': {'id': '202208064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colposcopy educational material', 'description': 'Participants will complete a 9-question quiz that will assess knowledge of colposcopy. They will then view the colposcopy educational material and answer the same 9-question quiz to assess their knowledge of colposcopy. Participants will complete the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Participants will also be asked whether the educational material influences their intention to adhere to colposcopy.', 'interventionNames': ['Other: Colposcopy educational material']}], 'interventions': [{'name': 'Colposcopy educational material', 'type': 'OTHER', 'description': '-Will consist of a handout featuring education and information regarding colposcopies.', 'armGroupLabels': ['Colposcopy educational material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Lindsay M Kuroki, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Association of Obstetricians and Gynecologists', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}