Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-08 @ 11:56 AM
Study NCT ID:
NCT02591433
Status:
WITHDRAWN
Last Update Posted:
2025-05-01
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Slow Accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2015-10-28', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who are adherent to smoking abstinence', 'timeFrame': 'Up to 6 months after completion of intervention', 'description': 'Calculated along with a 1-sided 95% exact confidence interval. An exact binomial test (with a one-sided alpha of 0.05) will also be used to test whether adherence is greater than 60%.'}], 'secondaryOutcomes': [{'measure': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores', 'timeFrame': 'Baseline to up to 6 months after completion of intervention', 'description': 'The scores for the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire will be evaluated for differences between the pre and post program states using analysis of variance using mixed models to allow for inclusion of all subjects with at least one measurement, with assessment of post-treatment to pre-treatment changes as the primary consideration. Longitudinal repeated measures using linear mixed models will be applied to assess the change from baseline as the outcome, and an exploratory analysis of potential clinical and demographic modifiers will be completed.'}, {'measure': 'Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores', 'timeFrame': 'Baseline to up to 6 months after completion of intervention', 'description': 'The scores for the Smoking Cessation Quality of Life (SCQoL) questionnaire will be evaluated for differences between the pre and post program states using analysis of variance using mixed models to allow for inclusion of all subjects with at least one measurement, with assessment of post-treatment to pre-treatment changes as the primary consideration. Longitudinal repeated measures using linear mixed models will be applied to assess the change from baseline as the outcome, and an exploratory analysis of potential clinical and demographic modifiers will be completed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Current Smoker', 'Malignant Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://kimmelcancercenter.org', 'label': 'Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center'}, {'url': 'http://hospitals.jefferson.edu/', 'label': 'Jefferson University Hospitals'}]}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies how well the "JeffQuit" group therapy program works in enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group therapy to provide psychological support and address the mental need for smoking, the habit or routine it creates, and the physical need for nicotine. It is not yet known how well the JeffQuit program will work in helping patients with a history of cancer to stop smoking.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the initial effectiveness of the JeffQuit program on smoking cessation in cancer patients.\n\nII. To assess the quality of life improvements related to the JeffQuit smoking cessation program in cancer patients.\n\nOUTLINE:\n\nPatients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.\n\nAfter completion of study, patients are followed up at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of cancer\n2. Current smoker\n3. Willing to provide consent and participate in the JeffQuit program\n4. Referral by a Kimmel Cancer Center provider\n\nExclusion Criteria:\n\n1. Any significant active medical disorder or physical condition that could reasonably be expected to interfere with the ability of the patient to quit smoking as determined by the Principal Investigator (PI)\n2. Currently participating in another smoking cessation program\n3. Currently receiving chemotherapy or radiation therapy that would interfere with their ability to participate in the JeffQuit program\n4. Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate\n5. Patients with current alcohol or drug abuse\n6. Enrollment in active clinical trial/ experimental therapy within the prior 30 days\n7. Are in the terminal stages of illness'}, 'identificationModule': {'nctId': 'NCT02591433', 'briefTitle': 'JeffQuit Group Therapy Program for Smoking Cessation in Patients With a History of Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Pilot Study of the Effectiveness of the JeffQuit Smoking Cessation Program', 'orgStudyIdInfo': {'id': '13D.423'}, 'secondaryIdInfos': [{'id': 'JT 2686', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (JeffQuit group therapy)', 'description': 'Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.', 'interventionNames': ['Other: Tobacco Cessation Counseling', 'Other: Support Group Therapy', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Tobacco Cessation Counseling', 'type': 'OTHER', 'otherNames': ['Tobacco Cessation Counseling, Tobacco Counseling'], 'description': 'Undergo JeffQuit group therapy', 'armGroupLabels': ['Supportive care (JeffQuit group therapy)']}, {'name': 'Support Group Therapy', 'type': 'OTHER', 'description': 'Undergo JeffQuit group therapy', 'armGroupLabels': ['Supportive care (JeffQuit group therapy)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment, Quality-of-Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (JeffQuit group therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Andrew Newberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}