Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 6:42 PM
Study NCT ID:
NCT01457469
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2011-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-30', 'studyFirstSubmitDate': '2011-10-21', 'studyFirstSubmitQcDate': '2011-10-21', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participation of patients with lunch cancer in the outpatient oncology setting', 'timeFrame': '1 year', 'description': 'Participation rate will be calculated as the proportion of the eligible patients who agree to participate.'}, {'measure': 'Accrual of patients with lung cancer in the outpatient oncology setting', 'timeFrame': 'Over 1 year', 'description': 'Estimated as the number of patients accrued divided by the number of months of accrual.'}, {'measure': 'Participant retention', 'timeFrame': '3 months', 'description': 'Estimated as the proportion of participating patients who complete questionnaires at the three month follow-up. Participants who discontinue the intervention but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by intervention arm. A Fisher exact test will be used to assess the difference in retention between the two arms. Kaplan-Meier methods will be used to estimate the time to drop-out, and a logrank test will be used to assess the difference in these distributions between treatment arms.'}, {'measure': 'Participant acceptance of the enhanced quitline-based smoking cessation intervention', 'timeFrame': '3 months', 'description': "Evaluated by summarizing the intervention participants' ratings of how much they liked and found the intervention and the interventionists to be helpful and sensitive to their concerns. Exact 95% confidence intervals (CI) will be calculated for these estimates. Open-ended questions regarding these issues will be summarized using qualitative methods."}, {'measure': 'Protocol fidelity', 'timeFrame': '3 months', 'description': 'Summarized by calculating the proportion of participants in both groups who report that they received advice from their physician to quit smoking, estimating the frequency with which intervention participants completed calls and calculating the mean duration of each call, and calculating the proportion of participants that utilized web-based services (including the frequency of the number of logins and sections visited and mean duration of visit).'}], 'secondaryOutcomes': [{'measure': 'Abstinence rate in both groups', 'timeFrame': '3 months'}, {'measure': 'Comparison of changes in quality of life, stress, and depressive symptoms between groups', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Limited Stage Small Cell Lung Cancer', 'Recurrent Small Cell Lung Cancer', 'Stage IA Non-small Cell Lung Cancer', 'Stage IB Non-small Cell Lung Cancer', 'Stage IIA Non-small Cell Lung Cancer', 'Stage IIB Non-small Cell Lung Cancer', 'Stage IIIA Non-small Cell Lung Cancer', 'Stage IIIB Non-small Cell Lung Cancer', 'Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies enhanced quitline intervention in smoking cessation for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may help patients with early-stage cancer quit smoking', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation intervention to lung cancer patients in the outpatient oncology setting.\n\nSECONDARY OBJECTIVES:\n\nI. To gather preliminary outcome data for an enhanced quitline-based smoking cessation intervention adapted to the outpatient oncology setting to support future grant applications.\n\nII. To evaluate change in primary patient reported outcomes, including quality of life (quantified by the Functional Assessment of Cancer Therapy - Lung \\[FACT-L\\] and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module \\[EORTC QLQ LC13\\]), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the Center for Epidemiological Studies Short Depression Scale \\[CESD-10\\]), in lung cancer patients in the intervention and control conditions (control arm closed to accrual as of 3/6/2012) from baseline to 3-months following randomization.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I (closed to accrual as of 3/6/2012): Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute\'s "Cleaning the Air" smoking cessation booklet.\n\nARM II: Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program.\n\nAfter completion of study treatment, patients are followed up at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosed with American Joint Committee on Cancer (AJCC) stage I-IIIa/b non-small cell lung cancer or limited stage small cell lung cancer Smoked any cigarettes in the past seven days Willing to consider quitting smoking\n\nExclusion Criteria:\n\nPatients with drug and alcohol abuse:\n\n* All patients will be assessed for alcohol use using a validated 1-item screening question; if positive, patients will be assessed using the validated Alcohol Use Disorders Identification Test (AUDIT) screening instrument, those with scores \\>= 8 (the validated cutoff) will be excluded\n* All patients will be assessed for drug use using a 1-item screening question: "How many times in the past month have you used an illegal drug or used a prescription medication for non-medical reasons?"; those with a response of \\>= 1 will be excluded Patient is unable to comprehend study documents and provide informed consent or Eastern Cooperative Oncology Group (ECOG) performance status is greater than two Patient does not read or understand English Patient refuses to participate Patient is contraindicated to receive nicotine replacement therapy: a) Patient is pregnant or breastfeeding, b) Patient has unstable cardiac disease within the past month (defined as unstable angina, myocardial infarction, serious arrhythmias, or any cardiac intervention procedure), or c) Patient is currently taking Chantix Patient does not have regular access to a phone to receive calls from the quitline'}, 'identificationModule': {'nctId': 'NCT01457469', 'briefTitle': 'Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting', 'orgStudyIdInfo': {'id': 'IRB00014657'}, 'secondaryIdInfos': [{'id': 'NCI-2011-02410', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CCCWFU 99310', 'type': 'OTHER', 'domain': 'Wake Forest University Health Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (usual care plus) (closed to accrual as of 3/6/2012)', 'description': 'Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute\'s "Cleaning the Air" smoking cessation booklet.', 'interventionNames': ['Other: questionnaire administration', 'Procedure: quality-of-life assessment', 'Other: educational intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (enhanced quitline)', 'description': 'Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program.', 'interventionNames': ['Other: questionnaire administration', 'Procedure: quality-of-life assessment', 'Other: counseling intervention', 'Other: internet-based intervention', 'Behavioral: telephone-based intervention', 'Drug: nicotine replacement therapy', 'Other: educational intervention']}], 'interventions': [{'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (usual care plus) (closed to accrual as of 3/6/2012)', 'Arm II (enhanced quitline)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (usual care plus) (closed to accrual as of 3/6/2012)', 'Arm II (enhanced quitline)']}, {'name': 'counseling intervention', 'type': 'OTHER', 'otherNames': ['counseling and communications studies'], 'description': 'Undergo counseling session', 'armGroupLabels': ['Arm II (enhanced quitline)']}, {'name': 'internet-based intervention', 'type': 'OTHER', 'description': 'Receive enhanced quitline intervention', 'armGroupLabels': ['Arm II (enhanced quitline)']}, {'name': 'telephone-based intervention', 'type': 'BEHAVIORAL', 'description': 'Receive enhanced quitline intervention', 'armGroupLabels': ['Arm II (enhanced quitline)']}, {'name': 'educational intervention', 'type': 'OTHER', 'otherNames': ['intervention, educational'], 'description': 'Receive usual care plus', 'armGroupLabels': ['Arm I (usual care plus) (closed to accrual as of 3/6/2012)']}, {'name': 'nicotine replacement therapy', 'type': 'DRUG', 'otherNames': ['Nicotine Replacement', 'NRT'], 'description': 'Receive nicotine replacement patches', 'armGroupLabels': ['Arm II (enhanced quitline)']}, {'name': 'educational intervention', 'type': 'OTHER', 'otherNames': ['intervention, educational'], 'description': 'Receive enhanced quitline intervention', 'armGroupLabels': ['Arm II (enhanced quitline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Kathryn Weaver', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}