Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-10 @ 4:52 PM
Study NCT ID:
NCT02723656
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2016-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proactive Care Coordination for Cancer Survivors Who Smoke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 581}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-07', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of patients in the study's original proactive outreach cohort of N=600 who complete at least one call with the Quitline", 'timeFrame': '12 Months'}], 'secondaryOutcomes': [{'measure': 'biochemically validated 7-day abstinence', 'timeFrame': '6 Months, 12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking', 'cancer', 'cancer registry', 'smoking cessation'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This is a population-based randomized controlled trial of 600 patients with a diagnosis of cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that will inform critical questions regarding the relative efficacy of care coordination options, the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will react to proactive tobacco related communications. Investigators will compare the reach and efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm 1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm randomized design at two urban cancer centers, and will explore cancer survivor attitudes and preferences about proactive tobacco treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICD 9 cancer diagnosis seen at each site in the past two years\n* Documentation of current smoking in the cancer registry.\n\nExclusion Criteria:\n\n* Dementia\n* Stage IV or Stage IIIB cancer'}, 'identificationModule': {'nctId': 'NCT02723656', 'briefTitle': 'Proactive Care Coordination for Cancer Survivors Who Smoke', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Using Cancer Registry Data to Promote Proactive Tobacco Cessation Among Adult Cancer Survivors U48', 'orgStudyIdInfo': {'id': '15-01069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Proactive mailed care coordination', 'interventionNames': ['Behavioral: Online Referral NYS Quitline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proactive telephone care coordination.', 'interventionNames': ['Behavioral: Tobacco cessation counseling and coordination of cessation medications']}], 'interventions': [{'name': 'Online Referral NYS Quitline', 'type': 'BEHAVIORAL', 'description': 'Care coordinator will make an online referral to the NYS Quitline.', 'armGroupLabels': ['Proactive mailed care coordination']}, {'name': 'Tobacco cessation counseling and coordination of cessation medications', 'type': 'BEHAVIORAL', 'description': 'Care coordinator will obtain verbal consent to transfer the patient to the NYS Quitline via 3-way call (warm transfer). The care coordinator will also assist the patient in obtaining NRT from a regular care provider, then call the patient every three months for 12 months to assess current smoking and offer to help smokers obtain additional cessation counseling and medications.', 'armGroupLabels': ['Proactive telephone care coordination.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Paul Krebs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}