Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT01630161
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2012-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smoking Relapse-Prevention Intervention for Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D006184', 'term': 'Habits'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Relapse at 6 Months', 'timeFrame': '6 Months', 'description': 'Number of participants with smoking relapse at 6 months follow-up for each treatment arm.'}, {'measure': 'Number of Participants with Relapse at 12 Months', 'timeFrame': '12 Months', 'description': 'Number of participants with smoking relapse at 12 months for each treatment arm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['relapse', 'prevention', 'smoking', 'habit', 'Forever Free'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test different ways to help cancer patients maintain their smoking abstinence. Participants may receive educational materials as part of the study.', 'detailedDescription': 'This study involves participation at four distinct time points over a one-year period.\n\n* Baseline assessment\n* 2-month follow-up telephone call\n* 6-month follow-up telephone call\n* 12-month follow-up telephone call'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have smoked at least 10 cigarettes per day for at least one year prior to cancer diagnosis\n* Able to read and write English\n* Able to give informed consent\n* Have quit smoking after receiving their cancer diagnosis\n* Have not quit greater than 3 months prior\n\nExclusion Criteria:\n\n* Individuals who have been abstinent for greater than 3 months are not included because they are less likely to relapse. A quit will be defined as self-reported no smoking for 24 hours. Individuals with metastatic disease will be excluded because participation in the study might be burdensome.'}, 'identificationModule': {'nctId': 'NCT01630161', 'briefTitle': 'Smoking Relapse-Prevention Intervention for Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Smoking Relapse-Prevention Intervention for Cancer Patients', 'orgStudyIdInfo': {'id': 'MCC-16458'}, 'secondaryIdInfos': [{'id': '5R01CA154596-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA154596-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants randomized to the Usual Care condition will receive standard care following recruitment.', 'interventionNames': ['Behavioral: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relapse-Prevention Intervention', 'description': 'Participants randomized to the Smoking Relapse Prevention for Cancer Patients (SRP-CaP) intervention will receive standard care plus our self-help smoking-relapse prevention materials.', 'interventionNames': ['Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)']}], 'interventions': [{'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': "Standard care includes routine assessment of smoking behavior and brief clinical intervention. Smoking counseling for all participants in the current study will be completed by a Certified Tobacco Treatment Specialist consisting consists of brief counseling (\\<15 minutes) based on the 5 A's Clinical Practice Guidelines; Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, Arrange for follow-up (Fiore et al., 2008). Patients receive information for local and state smoking resources (e.g., Quitline), pharmacotherapy options, and if interested, assistance with obtaining a prescription for pharmacotherapy. Follow-up with patients occurs at 2-weeks, only among those who are prescribed smoking medications (i.e., Varenicline, Bupropion).", 'armGroupLabels': ['Usual Care']}, {'name': 'Smoking Relapse Prevention for Cancer Patients (SRP-CaP)', 'type': 'BEHAVIORAL', 'description': 'The proposed multimodal intervention consists of a series of easy-to-read relapse prevention booklets (Forever Free) that have shown to be efficacious with a general smoking population (Brandon et al., 2000; 2004), and digital video disk (DVD) customized to the needs of cancer patients (to be developed in Year One).', 'armGroupLabels': ['Relapse-Prevention Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Vani Simmons, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}