Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 7:20 PM
Study NCT ID:
NCT04007458
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2019-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065822', 'term': 'College Fraternities and Sororities'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor will be blind to which intervention the subjects have received.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients will be randomly assigned to one of the following two groups:\n\n1\\. Control Group:\n\no Annual reminder letter only\n\n1. Intervention Group:\n2. Annual reminder letter and Community Health Worker proactive outreach'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completed low dose CT scan', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Percentage of patients who receive low dose CT scan within 3 months of the date on which they were initially contacted by letter'}], 'secondaryOutcomes': [{'measure': 'Scheduled low dose CT scan', 'timeFrame': 'through study completion, an average of one year', 'description': 'Percentage of patients who schedule a low dose CT scan within 3 months of the date on which they were initially contacted by letter'}, {'measure': 'Tobacco counseling', 'timeFrame': 'through study completion, an average of one year', 'description': 'Percentage of current smokers in the CHW phone call arm who receive counseling about tobacco treatment'}, {'measure': 'Maine Tobacco Helpline Referral', 'timeFrame': 'trhough study compeltion, an average of one year', 'description': 'Percentage of current smokers in the CHW phone call arm who accept referral to Maine Tobacco Helpline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This research study will test whether support from a Community Health Worker (CHW) to address barriers to annual LDCT screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter.', 'detailedDescription': 'This research study is a randomized controlled trial comparing phone outreach by a trained Community Health Worker (CHW) following a reminder letter to the reminder letter alone for patients who are at least a month overdue to have a routine annual low dose CT scan (LDCT) screening for lung cancer. CHWs will be able to identify and address barriers to accessing screening for those patients randomized to that arm of the study. Outcomes that will be measured include scheduling and completing the LDCT as well as agreeing to a referral for tobacco treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 or more pack years of tobacco use\n* If no longer using tobacco, no more than 15 years since last use\n* At least 13 months since last low dose CT scan screening\n\nExclusion Criteria:\n\n* Development of serious medical condition that would preclude treatment of lung cancer if found\n* Death since baseline screen'}, 'identificationModule': {'nctId': 'NCT04007458', 'briefTitle': 'Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder', 'orgStudyIdInfo': {'id': '1419555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Letter', 'description': 'Patients will receive a letter reminding them that they are overdue for repeat annual screening.', 'interventionNames': ['Behavioral: Letter']}, {'type': 'EXPERIMENTAL', 'label': 'Community Health Worker phone call', 'description': 'Patients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening.', 'interventionNames': ['Behavioral: Community Health Worker Phone Call']}], 'interventions': [{'name': 'Letter', 'type': 'BEHAVIORAL', 'description': 'MaineGeneral Radiology will generate a reminder letter about their need for an annual low dose CT scan to the subjects in this arm.', 'armGroupLabels': ['Letter']}, {'name': 'Community Health Worker Phone Call', 'type': 'BEHAVIORAL', 'description': 'Patients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening.', 'armGroupLabels': ['Community Health Worker phone call']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04330', 'city': 'Augusta', 'state': 'Maine', 'country': 'United States', 'facility': 'MaineGeneral Medical Center', 'geoPoint': {'lat': 44.31062, 'lon': -69.77949}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anne Conners', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anne Conners', 'investigatorAffiliation': 'MaineHealth'}}}}