- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02267096
Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Hospital and Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 55-80 years old
- current smoker
- > 30-pack years
- English-speaking
- ability to provide meaningful consent
- enrolled to undergo lung cancer screening. -
Exclusion Criteria:
- history of lung cancer
- current treatment for other cancer -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telephone Counseling (TC)
The TC arm will receive the list of minimal treatment interventions plus 3-6 sessions of stepped-care, proactive, telephone counseling.
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The TC arm includes a stepped care approach, 3-6 phone sessions, depending on each participant's needs.
Within 1-2 days post-T1 assessment, the intervention will begin.
Sessions 1-3 (15 min each) will occur approximately weekly over 3-4 weeks, scheduled at participants' convenience and at strategic therapeutic times (e.g., shortly pre/post-quit date).
Continuing smokers or newly quit former smokers who would benefit from relapse prevention sessions will receive up to 3 additional sessions, to be completed within 3-4 weeks.
The provision of 3-6 sessions is more intensive than several other telephone counseling interventions.
A dose response relationship between quitting and number of sessions has been shown in non-volunteer smokers, and based on our pilot data, the investigators expect that a more intensive intervention will be needed for some participants.
A list of self-help materials (print-, web-, phone-based), the national telephone quitline phone number, and local in person cessation resources will be given to all participants.
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Active Comparator: Minimal Treatment
The minimal treatment intervention includes a list of print, online, national telephone quitline phone number, and in-person cessation resources that is sent to participants.
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A list of self-help materials (print-, web-, phone-based), the national telephone quitline phone number, and local in person cessation resources will be given to all participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Status with biochemical verification
Time Frame: Measured at 3 months post-randomization
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Self-reported 7-day and 30-day point prevalence abstinence with biochemical verification among those who report having quit smoking.
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Measured at 3 months post-randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timeframe of Participants' Intention to Quit Smoking
Time Frame: Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)
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At each assessment, the investigators will ask for the timeframe of participants' intention to quit smoking. The question is worded as: "Next are statements that smokers and former smokers have said about quitting. Please tell me which statement best represents what you think right now." 1____ I enjoy smoking so much I will never consider quitting no matter what happens 2 ____ I never think about quitting but I might someday 3 ____I rarely think about quitting and have no specific plans to quit 4 ____I sometimes think about quitting but have no specific plans to quit 5 ____I often think about quitting but have no specific plans to quit 6 ____I plan to quit in the next 6 months 7 ____I plan to quit in the next 30 days 8 ____I have already begun to cut down and I have set a quit date |
Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)
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Quit attempts
Time Frame: Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)
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The questions are worded as follows:
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Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)
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Cigarettes per day
Time Frame: Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)
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The question is worded as follows: "Since our last interview, on average, how many cigarettes per day did you smoke?"
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Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Taylor KL, Cox LS, Zincke N, Mehta L, McGuire C, Gelmann E. Lung cancer screening as a teachable moment for smoking cessation. Lung Cancer. 2007 Apr;56(1):125-34. doi: 10.1016/j.lungcan.2006.11.015. Epub 2006 Dec 28.
- Barry SA, Tammemagi MC, Penek S, Kassan EC, Dorfman CS, Riley TL, Commin J, Taylor KL. Predictors of adverse smoking outcomes in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. J Natl Cancer Inst. 2012 Nov 7;104(21):1647-59. doi: 10.1093/jnci/djs398. Epub 2012 Oct 26.
- Tammemagi MC, Berg CD, Riley TL, Cunningham CR, Taylor KL. Impact of lung cancer screening results on smoking cessation. J Natl Cancer Inst. 2014 May 28;106(6):dju084. doi: 10.1093/jnci/dju084. Print 2014 Jun.
- Taylor KL, Hagerman CJ, Luta G, Bellini PG, Stanton C, Abrams DB, Kramer JA, Anderson E, Regis S, McKee A, McKee B, Niaura R, Harper H, Ramsaier M. Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial. Lung Cancer. 2017 Jun;108:242-246. doi: 10.1016/j.lungcan.2017.01.020. Epub 2017 Feb 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-541
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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