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Trial record 1 of 1 for:    NCT03059940
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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

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date September 16, 2019
Actual Study Start Date  ICMJE June 16, 2017
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Official Title  ICMJE Optimizing Effectiveness of Smoking Cessation Intervention During Low Dose CT Screening for Lung Cancer
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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: Nicotine Patch
    Nicotine patch dispensed. Dosing at physician's discretion.
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: Questionnaires
    • Procedure: Low Dose Computed Tomography Scan
    • Other: Shared Decision Making + Video
    • Behavioral: Cessation Counseling
    • Behavioral: Quitline
    • Drug: Nicotine Patch
    • Other: Carbon Monoxide (CO) Level Test
  • 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.

    Interventions:
    • Behavioral: Questionnaires
    • Procedure: Low Dose Computed Tomography Scan
    • Other: Shared Decision Making + Video
    • Behavioral: Cessation Counseling
    • Behavioral: Quitline
    • Behavioral: Pharmacotherapy Discussion
    • Drug: Anti-Smoking Drug
    • Other: Carbon Monoxide (CO) Level Test
  • 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,

    Interventions:
    • Behavioral: Questionnaires
    • Procedure: Low Dose Computed Tomography Scan
    • Other: Shared Decision Making + Video
    • Behavioral: Cessation Counseling
    • Behavioral: Pharmacotherapy Discussion
    • Drug: Anti-Smoking Drug
    • Behavioral: Tobacco Treatment Program
    • Other: Carbon Monoxide (CO) Level Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2017)
1260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Paul Cinciripini, PHD, MS, BS 713-792-0919 pcinciri@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03059940
Other Study ID Numbers  ICMJE 2016-0626
R01-CA 2027078-01 ( Other Grant/Funding Number: NCI )
NCI-2018-01219 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Principal Investigator: Paul Cinciripini, PHD, MS, BS M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP