Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS) (ScreenASSIST)
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| ClinicalTrials.gov Identifier: NCT03611881 |
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Recruitment Status :
Recruiting
First Posted : August 2, 2018
Last Update Posted : August 5, 2020
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | July 27, 2018 | |||||||||
| First Posted Date ICMJE | August 2, 2018 | |||||||||
| Last Update Posted Date | August 5, 2020 | |||||||||
| Actual Study Start Date ICMJE | April 8, 2019 | |||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Self-reported past 7-day smoking abstinence [ Time Frame: 6 Months after enrollment ] Patient self-report of no cigarette smoking in the past 7 days
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| Original Primary Outcome Measures ICMJE |
Biochemically-verified past 7-day abstinence from cigarette smoking [ Time Frame: 6 Months ] Patient report of no cigarettes smoked in the past 7 days (point prevalence abstinence), confirmed biochemically by saliva cotinine <=10 ng/ml or expired air carbon monoxide (CO) <10 ppm.
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS) | |||||||||
| Official Title ICMJE | Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening | |||||||||
| Brief Summary | This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose CT (LDCT) lung cancer screening. Using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (NRT) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources. | |||||||||
| Detailed Description | Evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. Nicotine patch is an FDA-approved cessation aid. The optimal duration of counseling and pharmacotherapy for patients undergoing low-dose CT (LDCT) lung screening is not clear. In addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. This randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine CT lung cancer screening. Patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months. | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 4 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Smoking, Tobacco | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
720 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | February 1, 2023 | |||||||||
| Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 55 Years to 80 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03611881 | |||||||||
| Other Study ID Numbers ICMJE | 2018P000539/PHS | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Elyse Park, PhD, Massachusetts General Hospital | |||||||||
| Study Sponsor ICMJE | Massachusetts General Hospital | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Massachusetts General Hospital | |||||||||
| Verification Date | August 2020 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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