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Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer

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ClinicalTrials.gov Identifier: NCT03059940
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Questionnaires Procedure: Low Dose Computed Tomography Scan Other: Shared Decision Making + Video Behavioral: Cessation Counseling Behavioral: Quitline Behavioral: Pharmacotherapy Discussion Drug: Nicotine Patch Drug: Anti-Smoking Drug Behavioral: Tobacco Treatment Program Other: Carbon Monoxide (CO) Level Test Early Phase 1

Detailed Description:

Study Groups:

If you are found to be eligible to take part in this study, you will have a CT scan of your chest to look for signs of lung cancer. You will receive the results 0-4 days after the scan. If there are any abnormal areas, you will be referred to your regular doctor for follow-up. No matter what the results are, you will be advised to quit smoking. If you have previously had a low dose CT scan for lung cancer screening in the last 30 days, you may still be eligible to participate in this study. You will be asked to provide documentation of the CT scan results.

You will receive a referral for counseling to help you reduce/quit smoking. You may also discuss medications you can take to reduce smoking.

As part of your counseling treatment, you may be prescribed an FDA-approved and commercially available anti-smoking drug. This may be either nicotine replacement therapy (such as a patch, gum, or lozenge) or an oral drug (such as varenicline or buproprion). The provider will tell you when and how much of your anti-smoking drug you should take each time, based on a discussion between you and your provider. Receiving anti-smoking medication will be done through your counseling treatment and not as part of your participation in this study.

You will have at least 5, but no more than 8, smoking cessation counseling sessions over the next 12 weeks. Each session will last between 30 - 60 minutes, in which you will set a quit date, prepare for your quit date, and discuss coping skills for dealing with smoking "triggers" after your quit date. You will also discuss challenges you may have with quitting.

Study Visits:

You will have 3 additional study visits, at around 6 weeks, 12 weeks, and 6 months after the screening visit, as well as 1 follow-up phone call. At all study visits:

  • You will complete questionnaires about several topics, including depression, suicide, and your smoking behavior. These questionnaires should take about 30-45 minutes in total to complete.
  • Your CO level will be measured.
  • Urine and/or saliva may be collected (at 12 weeks and 6 months only) for a routine test to check your cotinine and nicotine. Cotinine is a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked.

Follow-Up:

About 5 months after you start receiving counseling sessions, you will be called by a member of the study staff and asked about your recent smoking behaviors and habits. This call should last about 5-10 minutes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing Effectiveness of Smoking Cessation Intervention During Low Dose CT Screening for Lung Cancer
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Quitline (QL) Group

Questionnaires 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.

Behavioral: Questionnaires
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Other Name: Surveys

Procedure: Low Dose Computed Tomography Scan
Participants have a CT scan of chest to look for signs of lung cancer.
Other Name: LDCT

Other: Shared Decision Making + Video
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.

Behavioral: Cessation Counseling
Brief cessation counseling given by LDCT provider.

Behavioral: Quitline
Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

Drug: Nicotine Patch
Nicotine patch dispensed. Dosing at physician's discretion.

Other: Carbon Monoxide (CO) Level Test
Participant asked to blow air through a CO-measuring device.
Other Name: CO

Experimental: Quitline-Rx (QL-Rx) Group

Questionnaires 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.

Behavioral: Questionnaires
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Other Name: Surveys

Procedure: Low Dose Computed Tomography Scan
Participants have a CT scan of chest to look for signs of lung cancer.
Other Name: LDCT

Other: Shared Decision Making + Video
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.

Behavioral: Cessation Counseling
Brief cessation counseling given by LDCT provider.

Behavioral: Quitline
Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.

Behavioral: Pharmacotherapy Discussion
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.

Drug: Anti-Smoking Drug
Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.

Other: Carbon Monoxide (CO) Level Test
Participant asked to blow air through a CO-measuring device.
Other Name: CO

Experimental: Integrated Care (IC) Group

Questionnaires 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,

Behavioral: Questionnaires
Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Other Name: Surveys

Procedure: Low Dose Computed Tomography Scan
Participants have a CT scan of chest to look for signs of lung cancer.
Other Name: LDCT

Other: Shared Decision Making + Video
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.

Behavioral: Cessation Counseling
Brief cessation counseling given by LDCT provider.

Behavioral: Pharmacotherapy Discussion
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.

Drug: Anti-Smoking Drug
Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.

Behavioral: Tobacco Treatment Program
Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,
Other Name: TTP

Other: Carbon Monoxide (CO) Level Test
Participant asked to blow air through a CO-measuring device.
Other Name: CO




Primary Outcome Measures :
  1. Smoking Abstinence Rate [ Time Frame: 6 months ]
    Statistical power will focus on primary objective. Primary analyses use intention-to-treat (ITT) principles, with missing observations imputed as smoking.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 50 or older
  2. Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days) and is interested in treatment that might change smoking behavior.
  3. Meets guidelines for lung cancer screening, as determined by radiology team
  4. Able to follow verbal and written instructions in English and complete all aspects of the study.
  5. Provide informed consent and agree to all assessments and study procedures.
  6. Have an address and telephone number where he/she may be reached.
  7. Be the only participant in his/her household on active treatment in Protocol 2016-0626 at the time.
  8. Following good clinical practice guidelines, be medically suitable for one or more pharmacotherapies for smoking cessation including NRT, bupropion or varenicline, at provider discretion.
  9. Willing and able to undergo low dose CT scan, as determined by radiology team,or has had a lung cancer screen within 30 days of enrollment into this protocol.

Exclusion Criteria:

  1. Current enrollment or plans to enroll in another smoking cessation program in the next 9 months.
  2. Unwilling to refrain from other nicotine substitutes (i.e., OTC or prescription medication for smoking cessation) or smoking cessation treatments in the next 9 months.
  3. Current use of certain medications: (1) Smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, NRT, Chantix.
  4. A positive urine pregnancy test during the screening period. Women who are one year post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test.
  5. Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
  6. Exclusive use of tobacco products other than cigarettes, such as (but not limited to) cigars, chew, snuff, pipe or e-cigs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059940


Contacts
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Contact: Paul Cinciripini, PHD, MS, BS 713-792-0919 pcinciri@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       pcinciri@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Pfizer
Investigators
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Principal Investigator: Paul Cinciripini, PHD, MS, BS M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03059940     History of Changes
Other Study ID Numbers: 2016-0626
R01-CA 2027078-01 ( Other Grant/Funding Number: NCI )
NCI-2018-01219 ( Registry Identifier: NCI CTRP )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Low Dose computed tomography
Smoking Cessation
LDCT
Quitline
Questionnaires
Surveys
Counseling
Smoking cessation drugs
Anti-Smoking Drug
Nicotine replacement therapy
NRT
Nicotine Patch
Additional relevant MeSH terms:
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Nicotine
Carbon Monoxide
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Gasotransmitters