Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-01 @ 4:45 PM
Study NCT ID:
NCT01828502
Status:
WITHDRAWN
Last Update Posted:
2014-10-29
First Post:
2013-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was closed due to poor accrual. No patients were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-28', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-04-05', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in urine cotinine level', 'timeFrame': '4 weeks after baseline visit', 'description': 'The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.'}], 'secondaryOutcomes': [{'measure': 'Change in Self-Reported Smoking Behavior', 'timeFrame': '4 weeks after baseline visit', 'description': 'To determine whether urine cotinine feedback in conjunction with education provided to the caregiver is more effective in changing parental smoking behavior compared to education alone.'}, {'measure': 'Number of medical complications', 'timeFrame': '4 weeks after baseline visit', 'description': "As an exploratory measure we will collect history and physical exam data to follow patient's clinical complications during the study to determine if patients with a decrease in SHS exposure also have a decrease in clinical complications."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cotinine', 'Secondhand Smoke Exposure (SHSE)', 'Secondhand Smoke (SHS)'], 'conditions': ['Pediatric Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke.\n\nPURPOSE: This randomized study will compare education only to education plus cotinine feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that reside with a household smoker.', 'detailedDescription': "OBJECTIVES:\n\nThe primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.\n\nThe secondary objectives of this study are:\n\nTo determine whether urine cotinine feedback in conjunction with education provided to the caregiver is more effective in changing parental smoking behavior compared to education alone.\n\nAs an exploratory measure we will collect history and physical exam data to follow patient's clinical complications during the study to determine if patients with a decrease in SHS exposure also have a decrease in clinical complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 2 years and ≤ 12 years at the time of study entry.\n* Currently undergoing treatment for cancer at the time of enrollment, at least 28 days post diagnosis.\n* The child must reside 5 days a week with a household smoker (defined as a person who smokes greater than 10 cigarettes daily).\n* Child must be potty trained.\n* Parent/Legal Guardian ≥ 18 years of age.\n* Parent/Legal Guardian who accompanies the child to the first visit must accompany the child to all other visits. This person does not need to be the household smoker, but must be willing to educate the smoker on results at the visit and take the education handout home to them.\n* Parent/Legal Guardian must have a working phone to complete the week 5 follow-up phone call.\n* Able and willing to sign informed consent/assent.\n* Signed HIPAA compliant research authorization.\n\nExclusion Criteria:\n\n* Planned hospitalization within 3 days of any scheduled study visit (due to the urine cotinine measurement representing the previous 48-72 hours of tobacco exposure.\n* Inability to perform the initial cotinine test.'}, 'identificationModule': {'nctId': 'NCT01828502', 'briefTitle': 'Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer', 'orgStudyIdInfo': {'id': 'SCUSF 1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Intervention', 'description': 'Those randomized to the active intervention will receive education about secondhand smoke exposure and feedback using the cotinine test strip.', 'interventionNames': ['Behavioral: Education', 'Behavioral: Cotinine Education']}, {'type': 'OTHER', 'label': 'Education only', 'description': 'Those randomized to the education only group will receive only the education about secondhand smoke exposure.', 'interventionNames': ['Behavioral: Education']}], 'interventions': [{'name': 'Education', 'type': 'BEHAVIORAL', 'description': 'Participants in both groups will receive education by the EPA on the danger of exposure to secondhand smoke and how exposure can be prevented.', 'armGroupLabels': ['Active Intervention', 'Education only']}, {'name': 'Cotinine Education', 'type': 'BEHAVIORAL', 'description': 'Those randomized to the active intervention will also be provided with education utilizing the cotinine test strip in conjunction with the education from the EPA.', 'armGroupLabels': ['Active Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': "Lee Memorial Hospital - The Golisano Children's Hospital of Southwest Florida", 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Hospital", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33701', 'city': 'Saint Petersburgh', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital"}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}], 'overallOfficials': [{'name': 'Marisa Couluris, DO', 'role': 'STUDY_CHAIR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}