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| ID | Type | Description | Link |
|---|---|---|---|
| R01-CA 2027078-01 | Other Grant/Funding Number | NCI | |
| NCI-2018-01219 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Pfizer | INDUSTRY |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quitline (QL) Group | Experimental | 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. |
|
| Quitline-Rx (QL-Rx) Group | Experimental | 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. |
|
| Integrated Care (IC) Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason D Robinson, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39804633 | Derived | 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. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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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, |
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| Low Dose Computed Tomography Scan | Procedure | Participants have a CT scan of chest to look for signs of lung cancer. |
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| Shared Decision Making + Video | Other | 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. |
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| Cessation Counseling | Behavioral | Brief cessation counseling given by LDCT provider. |
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| Quitline | Behavioral | Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks. |
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| Pharmacotherapy Discussion | Behavioral | 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. |
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| Nicotine Patch | Drug | Nicotine patch dispensed. Dosing at physician's discretion. |
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| Anti-Smoking Drug | 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. |
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| Tobacco Treatment Program | Behavioral | Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period, |
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| Carbon Monoxide (CO) Level Test | Other | Participant asked to blow air through a CO-measuring device. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D014743 | Videotape Recording |
| D061485 | Tobacco Use Cessation Devices |
| C000628028 | thiamine triphosphorate |
| D002248 | Carbon Monoxide |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
| D013812 | Therapeutics |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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