Centralized Care Strategy for Smoking and Lung Cancer Screening

Not currently recruiting at 2 trial locations

Overseen By Robert J. Volk

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: History of lung cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people quit smoking and make decisions about lung cancer screening. It compares two strategies: one provides phone counseling sessions about quitting smoking and lung cancer screening, while the other offers usual care from primary care providers. The goal is to determine if centralized phone support helps more people quit smoking successfully and make informed screening decisions. The trial seeks current smokers who speak English, have a 30+ pack-year smoking history (smoking an average of one pack a day for 30 years), and have an upcoming primary care visit. As an Early Phase 1 trial, this research aims to understand how this new approach works in people, offering participants a chance to benefit from innovative support strategies.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation and lung cancer screening.

What prior data suggests that this centralized care strategy is safe for improving smoking cessation and decision making?

Research has shown that nicotine patches, commonly used to help people quit smoking, are generally easy to use. These patches release a small, steady amount of nicotine into the bloodstream, reducing cravings and withdrawal symptoms. The FDA has approved nicotine patches, indicating their safety. Some people might experience mild side effects like skin irritation where the patch is applied or dizziness, but these are usually not serious.

Studies have also shown that counseling to help people stop smoking is safe and effective. When combined with lung cancer screening, it can greatly increase the chances of quitting. This counseling typically involves personalized sessions to support individuals in quitting smoking. There are no major safety concerns with this approach, making it a reliable option for those wanting to quit.

Overall, both nicotine patches and smoking cessation counseling have a good safety record, making them suitable options for those participating in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Centralized Care Strategy for smoking cessation because it offers a fresh approach to quitting smoking by providing counseling over the phone. Unlike traditional methods where patients receive advice in person during a healthcare visit, this strategy allows for convenient, remote support over several weeks, making it easier for participants to integrate into their busy lives. Moreover, this method may include the use of nicotine patches, enhancing the potential for success by combining behavioral support with pharmacological aid. This innovative approach could lead to higher success rates in smoking cessation and improved lung cancer screening awareness, making it a promising option for individuals seeking to quit smoking.

What evidence suggests that this trial's centralized care strategy could be effective for smoking cessation and lung cancer screening?

Research has shown that counseling to help people stop smoking can be very effective, especially when combined with lung cancer screening. In this trial, participants in the centralized care strategy group will receive detailed phone counseling to help them quit smoking and learn about lung cancer screening, with the option to use nicotine patches. Programs that include both detailed counseling and stop-smoking medications have significantly helped smokers quit. One study found that attending eight counseling sessions led to higher quit rates than shorter programs. Additionally, using nicotine patches doubled the chances of staying smoke-free compared to a placebo over ten years. Quitting smoking is essential for lowering the risk and impact of lung cancer, and these treatments can help achieve that goal. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert J. Volk

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for current smokers with a history of heavy smoking (30+ pack-years), who are considering lung cancer screening and have an upcoming primary care visit. It's also for health providers caring for such adults. Participants must speak English, but those with a self-reported history of lung cancer cannot join.

Inclusion Criteria

English-speaking

Primary health care providers

People who receive most of their medical care from a general doctor or nurse practitioner.

Exclusion Criteria

I have been diagnosed with lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.

8 weeks

6-8 sessions (phone)

Follow-up

Participants are monitored for smoking abstinence and quality of decision-making about lung cancer screening

4 weeks

3 visits (1, 8, and 12 weeks)

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Patch
• Tobacco Cessation Counseling

Trial Overview The study is testing a centralized care strategy to improve quitting smoking and informed decision-making about lung cancer screening. This includes nicotine patches, counseling, questionnaires, quality-of-life assessments, and best practices compared to usual care.

How Is the Trial Designed?

Group I: Group I (centralized care strategy) Experimental Treatment 4 Interventions

Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.

Group II: Group II (usual care) Active Control 3 Interventions

Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.

Tobacco Cessation Counseling is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Smoking Cessation Counseling for:

• Smoking cessation during pregnancy
• Prevention of low birth weight
• Reduction of neonatal, perinatal, and infant morbidity and mortality

Approved in European Union as Tobacco Cessation Therapy for:

• Smoking cessation
• Prevention of smoking-related diseases

Approved in Canada as Nicotine Dependence Treatment for:

• Smoking cessation
• Treatment of nicotine addiction

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

Published Research Related to This Trial

Smoking cessation counseling provided by physicians and trained health professionals can lead to abstinence rates between 2.1% and 17.4%, indicating some effectiveness in helping people quit smoking.

However, the overall clinical effect of smoking cessation counseling is considered low, and long-term cessation rates remain uncertain, suggesting a need for further cost-effectiveness analyses before widespread implementation in public health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Counseling interventions for smoking cessation: systematic review]. Alba, LH., Murillo, R., Castillo, JS.[2019]

This study evaluates a proactive enrollment strategy linking lung cancer screening (LCS) smokers to a digital cessation intervention (web-based and text messaging), aiming to improve biochemically confirmed abstinence rates at 12 months post-randomization among 1650 participants.

The research will compare the effectiveness of a digital intervention alone versus one combined with tobacco treatment specialist counseling, with the expectation that the combined approach may yield higher quit rates, although it may be less cost-effective for implementation in LCS programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial. Graham, AL., Burke, MV., Jacobs, MA., et al.[2019]

Smoking cessation after a lung cancer diagnosis significantly improves survival rates and quality of life, highlighting the importance of quitting even after diagnosis.

Effective treatments for tobacco dependence exist, but achieving long-term cessation may require persistent support and multiple interventions from healthcare professionals, particularly oncology nurses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation and lung cancer: oncology nurses can make a difference. Cooley, ME., Sipples, RL., Murphy, M., et al.[2021]

Tobacco use remains the largest preventable risk factor for cancer, and its continued use among cancer patients leads to worse health outcomes, highlighting the need for effective cessation support.

Integrating tobacco cessation support into lung cancer screening and treatment is feasible and can significantly improve patient health and treatment outcomes, yet most cancer patients currently do not receive this essential support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening, Cancer Treatment, and Addressing the Continuum of Health Risks Caused by Tobacco. Warren, GW., Ostroff, JS., Goffin, JR.[2023]

In a study of 4448 smokers, medical diagnoses were the most common reason for attempting to quit smoking, cited by 48% of participants, indicating that health concerns play a significant role in the decision to stop smoking.

Successful quitting was more likely among older, male, and non-Hispanic White individuals, suggesting that demographic factors and the severity of nicotine dependence also influence smoking cessation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Medical Diagnosis on Decision to Stop Smoking and Successful Smoking Cessation. Lindsay, HG., Wamboldt, FS., Holm, KE., et al.[2022]

A randomized controlled trial involving 496 participants (245 in the proactive counseling group and 251 in the control group) found that proactive telephone counseling did not significantly improve smoking cessation rates overall, but younger participants (<50 years) showed a higher cessation rate at 2 weeks (16% vs. 4%).

The study suggests that while proactive counseling aimed at teaching coping skills was challenging to implement, it may still hold potential for younger smokers in the social networks of lung cancer patients, indicating a need for further research to optimize such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. Bastian, LA., Fish, LJ., Peterson, BL., et al.[2022]

In a study involving 315 smokers aged 55 to 75 participating in a targeted lung health check, an immediate telephone smoking cessation intervention significantly increased quit rates at 3 months (21.1% vs 8.9%) compared to usual care.

The intervention, which included intensive support and pharmacotherapy, was effective regardless of participants' smoking history or any abnormalities found in their lung scans, highlighting its broad applicability in lung cancer screening contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate, Remote Smoking Cessation Intervention in Participants Undergoing a Targeted Lung Health Check: Quit Smoking Lung Health Intervention Trial, a Randomized Controlled Trial. Williams, PJ., Philip, KEJ., Gill, NK., et al.[2023]

The National Lung Screening Trial showed that low-dose computed tomography (LDCT) significantly reduces lung cancer mortality and overall mortality in high-risk individuals aged 55-74 with a history of heavy smoking (30 pack-years).

Integrating smoking cessation resources into lung cancer screening programs is crucial, as it not only helps reduce lung cancer risk but also addresses other smoking-related diseases, ultimately aiming to improve the overall health and longevity of screened patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of smoking cessation and lung cancer screening. Steliga, MA., Yang, P.[2023]

The SCALE collaboration involves eight clinical trials aimed at improving smoking cessation strategies for older smokers (aged 55-80) with a significant smoking history, specifically in the context of lung cancer screening.

These trials address key methodological issues, such as participant eligibility and treatment delivery, to optimize smoking cessation outcomes and leverage the 'teachable moment' provided by lung cancer screening results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening and Smoking Cessation Clinical Trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration. Joseph, AM., Rothman, AJ., Almirall, D., et al.[2022]

From 2011 to 2015, the percentage of current smokers discussing smoking cessation with healthcare professionals increased from 51.3% to 55.4%, indicating a gradual improvement in these important health conversations.

Despite this increase, over 40% of current smokers, including 15% who underwent lung cancer screening, did not have or could not recall discussions about smoking, highlighting a significant gap in smoking cessation counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider-Patient Discussions About Smoking and the Impact of Lung Cancer Screening Guidelines: NHIS 2011-2015. Huo, J., Chung, TH., Kim, B., et al.[2021]

Participants referred to smoking cessation programs through lung cancer screening had a low quit rate of only 12% at six months, indicating that phone counselling alone is not very effective in this context.

In contrast, individuals referred by healthcare workers had significantly higher quit rates, being twice as likely to quit compared to those referred by lung cancer screening programs, suggesting the need for more personalized and dedicated tobacco treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation by Phone Counselling in a Lung Cancer Screening Program: A Retrospective Comparative Cohort Study. Ghatak, A., Gilman, S., Carney, S., et al.[2022]

Quitting tobacco after a lung cancer diagnosis can significantly improve prognosis, overall health, and quality of life, highlighting the critical need for effective tobacco dependence treatment in cancer care.

Integrating tobacco treatment into lung cancer screening programs presents a valuable opportunity to further decrease lung cancer mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary and Secondary Prevention of Lung Cancer: Tobacco Treatment. Kathuria, H., Neptune, E.[2020]

Citations

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Tobacco Dependence Predicts Higher Lung Cancer and ... Patients with high dependence scores were less likely to quit smoking compared with low dependence smokers (TTFC OR, 0.50 [95% CI, 0.42-0.60]).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2945268/

Smoking Cessation: An Integral Part of Lung Cancer ... There are significant positive effects of smoking cessation on the health of lung cancer patients: decreased risk of disease, increased survival time, decreased ...

3. actaorthop.org actaorthop.org/actaoncologica/article/download/35188/40253

The effect of a smoking cessation program for patients in ... Background: Compared to non-smokers, smokers have reduced effects of cancer treatment, and increased risk of treatment-related toxicity. Quitting smoking ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1326020023015248

Ten‐year survival outcome of the nicotine transdermal ... At 10 years, the active nicotine patch group showed significantly higher continuous abstinence rates that were double those of the placebo group (7.9% vs. 2.6%, ...

5. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/jan-2024-durb-agenda-item5ee.pdf

Smoking Cessation Agents Review Clinicians should consider varenicline 2 mg daily or the combination of nicotine patch plus another form of NRT to be more effective than the nicotine patch.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/020165Orig1s047lbl.pdf

Nicoderm CQ - accessdata.fda.gov Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to ...

7. goodrx.com goodrx.com/nicoderm-cq/what-is?srsltid=AfmBOoocqWxVPWiP6qXk0rL8qHUERiSnI0ZCN8hAhz3zRmRkgXt9Mv65

Nicotine patch (Nicoderm CQ): Uses, Side Effects, Tips & ... It lowers your nicotine cravings and helps prevent nicotine withdrawal symptoms, without exposing you to the harmful chemicals found in tobacco products. info.

8. webmd.com webmd.com/drugs/2/drug-75256-746/nicotine-polacrilex-buccal/nicotine-lozenge-buccal/details

Nicotine (NicoDerm, Nicorette, and others) - Uses, Side ... Nicotine is used to help reduce withdrawal symptoms from quitting smoking. Common side effects vary based on the form of nicotine that you use.

9. mayoclinic.org mayoclinic.org/drugs-supplements/nicotine-transdermal-route/description/drg-20068808

Nicotine (transdermal route) - Side effects & dosage Nicotine skin patches are used to help you stop smoking. Nicotine is absorbed from the patch on the skin and enters the blood stream.

10. healio.com healio.com/clinical-guidance/drugs/nicoderm_cq

Nicoderm CQ: Uses, Side Effects & Dosage Find clinical guidance on Nicoderm CQ, including indications, dosing, safety, side effects and evidence-based insights for healthcare ...