Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Optimizing Effectiveness of Smoking Cessation Intervention During Low Dose CT Screening for Lung Cancer
3 other identifiers
interventional
630
1 country
1
Brief Summary
The goal of this clinical research study is to offer lung cancer screenings to smokers who want to change their smoking behaviors. All eligible participants will receive smoking cessation counseling and may be offered at least one form of smoking cessation drug. Different forms of counseling (the delivery of counseling and access to counseling) will be compared. This is an investigational study. Participants on this study will not be prescribed smoking drugs directly by the study staff. However, participants in this study may or may not receive smoking cessation drugs, depending on what the provider thinks is in the participants best interest. All smoking cessation drugs being used are FDA approved and commercially available. It is investigational to compare the different forms of counseling participants receive. Up to 1260 participants will be enrolled in this study. All will take part at MD Anderson.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2017
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 15, 2026
April 1, 2026
9 years
February 17, 2017
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Abstinence Rate
Statistical power will focus on primary objective. Primary analyses use intention-to-treat (ITT) principles, with missing observations imputed as smoking.
6 months
Study Arms (3)
Quitline (QL) Group
EXPERIMENTALQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participants given shared decision making and discussion about screening with the LDCT provider. Participants referred to the Quitline for counseling and NRT (nicotine patch). Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Quitline-Rx (QL-Rx) Group
EXPERIMENTALQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. LDCT provider and patient discuss options for pharmacotherapy. Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Integrated Care (IC) Group
EXPERIMENTALQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,
Interventions
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Participants have a CT scan of chest to look for signs of lung cancer.
Participants given shared decision making and discussion about screening with the LDCT provider. Participants watch a short video about lung cancer, CT scans, and smoking cessation.
Brief cessation counseling given by LDCT provider.
Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Participant informed of the risk, benefits and relative efficacy of cessation medications and to assess their medication preferences, expectations and medical suitability for either option. At the conclusion of this conversation the patient is provided with an initial supply of the medication jointly decided between provider and patient.
Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.
Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,
Participant asked to blow air through a CO-measuring device.
Eligibility Criteria
You may qualify if:
- Age: 50 or older
- Meets guidelines for lung cancer screening, as determined by radiology team
- Reports being a daily or non-daily smoker (any self-reported smoking in the past 30days) and is interested in treatment that might change smoking behavior.
- Able to follow verbal and written instructions in English and complete all aspects ofthe study.
- Provide informed consent and agree to all assessments and study procedures.
- Have an address where he/she can receive mail
- If opting to participate in telemedicine visits, must have a device available to conduct telehealth visits (e.g., smartphone, computer, tablet, etc.).
- Be the only participant in his/her household on active treatment in Protocol 2016-0626at the time.
- Willing and able to undergo low dose CT scan, as determined by radiology team, and has either had a lung cancer screen within 30 days prior to enrollment into this protocol or schedules a LDCT scan for lung cancer screening to occur while taking part in the 2016-0626 protocol.
You may not qualify if:
- Current enrollment or plans to enroll in another smoking cessation program in the next6 months.
- Unwilling to refrain from other nicotine substitutes use (i.e., OTC orprescription medication for smoking cessation) or smoking cessation treatments during the course of the the active treatment portion of the study other than what is provided to or recommended for use.
- Current use of certain medications: (1) Smoking cessation meds (last 7 days), that are being used as part of a current attempt to quit smoking i.e., Wellbutrin, Bupropion, Zyban, NRT, Chantix.
- Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report..Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such asbirth control pills, patches, implants or injections), (2) barrier methods (such as a condomor diaphragm) used with a spermicide, or (3) an intrauterine device (IUD).Contraceptive measures sold for emergency use after unprotected sex are not acceptable methodsfor routine use.
- Exclusive use of tobacco products other than cigarettes or little cigars, such as (but not limited to) cigars, chew, snuff, pipe or e-cigs.
- Individuals who are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or study physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Pfizercollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Cinciripini PM, Minnix JA, Kypriotakis G, Erasmus J, Beneventi D, Karam-Hage M, Carpenter K, Volk RJ, Carter B, Godoy MCB, Strange C, Shih YT, Cui Y, Green CE, Robinson JD. Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Randomized Clinical Trial. JAMA Intern Med. 2025 Mar 1;185(3):284-291. doi: 10.1001/jamainternmed.2024.7288.
PMID: 39804633DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason D Robinson, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2017
First Posted
February 23, 2017
Study Start
June 16, 2017
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04