Centralized Care Strategy for Smoking and Lung Cancer Screening

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

358 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

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 data supports the idea that Centralized Care Strategy for Smoking and Lung Cancer Screening is an effective treatment?

The available research shows that the Centralized Care Strategy for Smoking and Lung Cancer Screening is effective because it combines different methods to help people quit smoking, which can improve health outcomes for those with lung cancer. For example, one study highlights that quitting smoking after a lung cancer diagnosis can lead to better health and quality of life. Another study suggests that using proactive telephone counseling along with self-directed interventions can be more effective in helping people quit smoking than self-directed efforts alone. Overall, these strategies are shown to reduce the risk of cancer-related and other health issues, making them a valuable approach for those at risk or undergoing treatment for lung cancer. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for smoking cessation and lung cancer screening?

Research shows that quitting smoking after a lung cancer diagnosis can improve cancer outcomes and overall health. Combining tobacco cessation support, like counseling and nicotine patches, with lung cancer screening can significantly reduce the risk of death from lung cancer. ^{1 2 3 4 5}

What safety data exists for smoking cessation treatments?

The safety of smoking cessation treatments, including counseling and pharmacological interventions like nicotine patches, has been evaluated in various studies. A systematic review focused on the efficacy and safety of smoking cessation counseling. Additionally, clinical trials, such as those in the SCALE collaboration, are designed to assess the effectiveness and safety of smoking cessation treatments in the context of lung cancer screening. These trials consider factors like treatment delivery methods and participant eligibility, which can impact safety outcomes. ^{2 6 7 8 9}

Is smoking cessation counseling safe for humans?

Smoking cessation counseling, which includes support and guidance to help people quit smoking, is generally considered safe for humans. It is a recommended practice in clinical guidelines for lung cancer screening and has been widely used without significant safety concerns. ^{2 6 7 8 9}

Is Tobacco Cessation Counseling a promising treatment for smoking and lung cancer screening?

Yes, Tobacco Cessation Counseling is a promising treatment. It helps people quit smoking, which can reduce the risk of lung cancer and other diseases. Combining counseling with lung cancer screening can improve health outcomes and help people live longer, healthier lives. It is effective, especially when integrated with digital tools and proactive support. ^{1 2 10 11 12}

How is Tobacco Cessation Counseling unique compared to other smoking cessation treatments?

Tobacco Cessation Counseling in the context of lung cancer screening is unique because it often integrates proactive and remote support, such as telephone counseling and digital interventions, which can be more effective and accessible than traditional face-to-face methods. This approach is tailored to individuals undergoing lung cancer screening, making it a novel strategy to enhance smoking cessation efforts in this specific population. ^{1 2 10 11 12}

Research Team

Robert J. Volk

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of a Medical Diagnosis on Decision to Stop Smoking and Successful Smoking Cessation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Primary and Secondary Prevention of Lung Cancer: Tobacco Treatment. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation and lung cancer: oncology nurses can make a difference. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening, Cancer Treatment, and Addressing the Continuum of Health Risks Caused by Tobacco. [2023]

6. Mexico pubmed.ncbi.nlm.nih.gov

[Counseling interventions for smoking cessation: systematic review]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Provider-Patient Discussions About Smoking and the Impact of Lung Cancer Screening Guidelines: NHIS 2011-2015. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening and Smoking Cessation Clinical Trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration. [2022]

9. Egypt pubmed.ncbi.nlm.nih.gov

Smoking Cessation by Phone Counselling in a Lung Cancer Screening Program: A Retrospective Comparative Cohort Study. [2022]

10. United States 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. [2023]

11. China pubmed.ncbi.nlm.nih.gov

Integration of smoking cessation and lung cancer screening. [2023]

12. England pubmed.ncbi.nlm.nih.gov

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial. [2019]